To
The Members,
Your Directors have pleasure in presenting their Report on the business
and operations of the Company along with the Standalone and Consolidated Audited Financial
Statements for the year ended March 31, 2024.
Financial Summary
(All figures are in Rupees in Lakhs)
Particulars |
FINANCIAL
YEAR 2023-24 |
FINANCIAL
YEAR 2022-23 |
Standalone |
Consolidated |
Standalone |
Consolidated |
Continued Operations: |
|
|
|
|
Operating revenue |
30,978.67 |
1,15,160.30 |
24,770.20 |
1,05,011.24 |
Other Income |
8,911.60 |
817.05 |
6,864.42 |
1,739.97 |
Profit before interest, depreciation, tax and
after exceptional Items from continuing operations |
10,495.66 |
25,879.83 |
909.66 |
11,968.14 |
Interest |
1,725.66 |
9,180.94 |
2,082.51 |
5,865.21 |
Depreciation & Amortisation |
4,961.09 |
10,786.99 |
4,654.75 |
9,549.90 |
Net profit/(loss) before tax from continuing
operations |
3,808.91 |
5,911.90 |
(5,827.60) |
(3,446.97) |
Provision for taxes |
|
|
|
|
a.current tax/(credit) |
1,128.65 |
4,529.50 |
(836.56) |
3,413.10 |
b.Deferred Tax/(credit) (Net of MAT credit) |
(13.48) |
(2,290.95) |
(42.74) |
(4,143.76 ) |
Profit after tax from continuing operations |
2,693.74 |
3,673.35 |
(4,948.30 ) |
(2,716.31) |
Discontinued operations : |
|
|
|
|
Profit/ (loss) before tax from
discontinued operation |
- |
- |
7,095.22 |
- |
Tax expense/(credit) of discontinued
operation |
- |
- |
3,572.38 |
- |
Profit/(Loss) after tax from discontinued
Operations |
- |
- |
10,667.60 |
- |
Profit for the year from continuing and
discontinued operations |
2,693.74 |
3,673.35 |
5,719.30 |
(2,716.31) |
Share of profit/(Loss) in Associates/ Joint
Ventures |
- |
(477.84) |
- |
(380.97) |
Share of profit/(Loss) in Non-Controlling
interest |
- |
(8.09) |
- |
(156.04) |
Other comprehensive incomes (expenses)
(Continued and Discontinued operations) |
(165.63) |
(237.06) |
428.59 |
328.34 |
Total Comprehensive Income/(expenses) |
2,528.11 |
2,950.36 |
6,147.89 |
(2,924.98) |
REVIEW OF OPERATIONS:
During the year under review, the Company reported standalone operating
revenues of C30,978.67 Lakhs as against C24,770.20 Lakhs and Total Comprehensive Income of
C 2,528.11 Lakhs as against C 6,147.89 Lakhs in the previous year, consolidated gross
revenues for the year review were reported at C 1,15,160.30 Lakhs as against C 1,05,011.24
Lakhs and Total Comprehensive Income/ (loss) of C2,950.36 Lakhs as against C (2,924.98)
Lakhs in the previous year.
Active Pharma Ingredients
SHILPA PHARMA LIFESCIENCES LIMITED (Wholly owned subsidiary)-API
FACILITIES
Shilpa has two world class State-of-art API manufacturing facilities at
Raichur, supported by strong & efficient team of R&D, IPM, Production,
Engineering, Quality Control,
Quality Assurance, Corporate Quality Assurance and Regulatory functions
with other supportive functions & well administered Human Resource management. The
facilities are cGMP Complaint & approved by many national & international
regulatory bodies like USFDA, EU, Cofepris- Mexican, PMDA-Japan, Korean FDA, TPD Canada,
TGA-Australia & ANVISA Brazil
The Company is having about 20 API's & intermediate manufacturing
blocks with segregation of Oncology and Non-Oncology manufacturing facilities. Oncology
products are manufactured & handled with high level of containment & taking care
of people & environment. Oncology Blocks designed to handle small scale, medium scale
& high-volume scale to handle different levels of Batch size like 500 gm to 350 kg and
Non-Oncology batch sizes from 4 kg to 2,000 kg.
The API facilities are certified for ISO9001:2015 for quality
Management systems, ISO14001:2015 for
Environmental management systems, ISO45001:2018 for occupational health
& safety systems,ISO50001:2018 for Energy Management Systems & SA8000:2014 for
Social accountability Management system & R&D is certified by DSIR, Govt. of
India.
Shilpa is the first Company to invest in India on containment
technologies for the manufacturing of oncology drug substances in a contained environment
& also latest technologies like Bipolar system from Japan to ensure the manufacturing
process are sustainable with less consumption of natural resources & safe operations,
we have expanded with 2nd system in FY2023-24. These innovative Technologies provide us
the sustainable process which are validated & commercialized. Adopting these novel
technologies makes the Company conserve the resources & make our processes environment
friendly and give the Company an edge in penetrating the new markets & innovator
companies.
As an environmentally conscious Company , we focus on reduce,
recycle& reuse of the wastes generated. The Company recycles 100% waste water by
treating in its Zero liquid discharge effluent treatment plant. The Company reduces the
resource usage for treatment by segregating the liquid wastes based on the TDS&COD.
The Company monitors & controls scope-1, scope-2 & scope-3 emissions. The fugitive
emissions from the reactors are effectively scrubbed , all the storage facilities solvents
are connected to the heat exchangers with chilled water to prevent the air pollution due
to evaportaion from the storage tanks . The air quality is monitored in the premises work
areas are monitored for Volatile Organic Content & effective control measures are in
place to keep the emissions in control. The Company has reduced the emissions to the
extent of about 10000 Tons of GHG emissions year on year by using the renewable fuel
Biomass in place of the Fossil fuel for its thermal energy requirements. This project was
registered with UNFCC. The Company is UNGC participant & submitted its performance for
the FY-23-24 , & is listed on their site. The Company is signatory to SBTI( Science
based Targets Initiative ) by committing to become Net Zero by the year 2040. The Company
undertakes the targets for the reduction of the wastes & resourse usage by the
involving the whole site team.
The solvents are recovered, purified and reused in its processes and
reduces the resource usage, both the facilities are equipped with fractional distillation
columns .
The Company strongly believes in sustainable growth by focussing on the
ESG systems. All the employees are trained on the ESG aspects. Risks are assessed and
mitigation measures and recommendations are implemented by conducting HIRA, Hazop, IH,
Process safety modules review. The necessary infrastucture for fire fighting and loss
prevention is in place.
The Company understands the importance of involvement of its own
employees as the drivers for ensuring the safe operations at the sites & nominated the
safety Co-ordinators , safety squad & emergency response teams . The best training is
imparted by external subject experts, state level Fire authorities and practicing the
emergency procedures by mockdrills. These drills are monitored by District Authorities.
The Company has hired Subject matter expert to advise and guide the operational team on
ESG aspects and ensure the compliance.
The API Facilities are equipped with all the utilities to support the
process requirements like wide range of temperatures from -50?C to 300?C, purified
water, HVAC, clean rooms, nitrogen, compressed air.
The Utilities performance w.r.t capacity, efficiency are monitored by
well trained personnel supported by original equipment manufacturers with a deep drive
towards energy conservation.
The state of art Quality Control Facility is well equipped for testing
and release of Finished goods, Raw Materials, Intermediates, with QMS in place.
The Company has made utilisation of the existing capacity more
effectively by bifurcating the intermediate areas into two bay system, to run the two
products at the same time with out cross contamination, thereby the opportunity of
manufacturing multiple products at a time.
The Company is creating additional capacity 10MT per month for one of
its niche molecule Tranexamic Acid, from the current capacity of 14MT per month. This
expansion activity will start will commence the production from Jan 2025.
In the FY2023-24 the Company's strong hold product Ambroxol Hcl
capacity was increased from 135 MT to 175MT per annum by optimally utilising the ambroxol
manufacturing facility and by making the manufacturing equipment into two bays, and the
capacity enhancement to 230MT is underway by debottlenecking of some of the equipment
within the same facility.
Shilpa proved its Capability and Capacity manufacturing and selling
about 175MT Ambroxol and 165MT Tranexamic acid.
The Company has added new manufacturing facility in the existing
premises with about 85 KL volume with higher size reactors to ensure UDCA scale is
increased and business volume enhanced from 48MT of FY 2022-23 to 100 MT in FY 2023-24 and
planning to further expand to 150 MT in FY 2024-25.
Polymer R&D & Peptide R&D of Shilpa is fully functional
& started commercial products. One of our Polymer Products transformed to commercial
scale which will have substantial addition going forward. The Company has filed CEPs for
the 2 No's of peptide molecules with this Shilpa stepped up in Peptide & extended its
wings in regulatory market in this new segment.
SHILPA PHARMA -R&D (API)
As an essential part of its business strategy, the Company sees its
consistently excellent R&D skills as what allows it to consistently develop new
medicines and offer a long- term, sustainable competitive advantage. As one of the few
Indian pharmaceutical firms with a strong R&D foundation, the Company is committed to
mastering a variety of chemistries and value chains to meet its worldwide regulatory
aspirations. The Company is committed to being a leader in the specialty API and oncology
generics markets, which is reflected in its R&D environment. By introducing generic
medications to the market as soon as possible and making them accessible to as many
patients as possible, our generics business helps to lower drug prices for individuals and
governments. This is accomplished by mastering multiple chemistries and value chains. We
provide affordable, superior medicine.
The Company will keep up its major efforts to support affordability,
aim to diversify its generic product line, and concentrate on boosting accessibility to
goods with high entry barriers. We will continue searching for fresh approaches to expand
the patient base for generics, working with multinational players to establish long-term
manufacturing relationships.
Our research and development center's proficiency in managing diverse
chemistries, including grignard, organolithium, organometallic, and cross-coupling
reactions, provides room for the creation of innovative generics that adhere to global
regulatory standards. This includes complex API generics that are challenging to make like
those for the oncology / non-oncology space.
The effective flow chemistry team at the Company is working hard and
has successfully demonstrated two products in the market. In FY2024-25, they plan to
demonstrate a pipeline of four more products. This is where close handling really shines.
With a robust R&D foundation, Company began synthesizing the
essential impurities needed for the development of new APIs as well as those needed to set
up an effective control strategy and resolve regulatory DMF deficiencies for Drug Master
Files (DMFs) that were filed, all in an effort to save time and money.
The R&D department helps the Company consistently develop new
products and provide alternatives to the KSMs and Intermediates that are being imported in
bulk from China. By focusing on the downstream chemistries, the R&D team began working
toward self-reliance on KSMs and intermediates.
In order to save production costs, achieve global leadership, and
achieve sustainable growth, Shilpa R&D consistently concentrates on new technologies
and efforts to improve the commercialized APIs' processes.
SHILPA MEDICARE- FINISHED DOSAGE FORMULATION FACILITY
Shilpa Medicare Limited - Finished Dosage Formulation Facility is a
state of the art manufacturing and testing facility, engaged in manufacturing and
distribution of potent drugs- which includes liquid and lyophilized injectables in vials,
sterile dry powder injectables in vials, oral solid dosage form (Tablets and hard gelatine
capsules) into various regulated and rest of the world markets, including US and EU.. The
facility is designed for handling of potent Drug Products (including Oncology products or
adjutant therapies) in a fully contained manner. Facility is designed to handle potent
molecules up to OEL 4 level of containment.
The facility is approved by various regulatory agencies, including EUGMP-AGES-Austria,
ANVISA, Health Canada, Peru, Argentina, South Africa, COFEPRIS Mexico, TGA -Australia,
Ministry of Health- UAE & UKMHRA.
For USFDA, currently the facility is under Import Alert, however; USFDA
has exempted three products from the Import Alert. Shilpa Medicare Unit 4 is distributing
these three products (Azacitidine for Injection, Erlotinib Capsules and Cyclophosphamide
Capsules), in the US market. Supplies to Europe are going on uninterrupted.
This facility consists of Oral Solid Block with two commercial scale
tablet manufacturing and one commercial scale capsule manufacturing line. There are two
blister packing lines and one Bottle filling line.
Fully automatic packaging lines are available for Injectables in vial
presentation and for Oral solid dosage forms in bottles and blister presentations. The
Injectable Packaging lines are designed for safe packaging for Onco Injectables.
Serialization (Track and Trace) is in place and implemented as per
market requirement for commercial supplies.
The facility is supported by state of art utilities like purified
water, WFI, pure steam, chillers, air compressors, Boilers , Power generators & HVAC ,
helping the Company to ensure the compliance in process & work environment.
All world class process equipment are provided with 21 CFR part 11
compliant SCADA systems.
Fully equipped and approved chemical testing Laboratories and
Microbiology laboratory are operational with trained and qualified staff.
Commercial presence in various regulated, emerging markets and domestic
markets in injectable and oral solid dosage forms.
Capacities:
Liq. Inj. - 12.6 million/Annum.
Lyo. Inj.- 2.32 million/Annum Dry powder Inj.- 0.67 million/Annum
Tablets: 33.5 million/Annum Capsules: 27 million/Annum.
Contract Manufacturing
Shilpa Medicare Limited manufactures many products in several types of
dosage forms such as tablets, capsules, liquid injection (Aseptically and terminally
sterilized), Lyophilized Injectable, etc for various reputed pharmaceutical organisations
across the world.
All products are manufactured under the same stringent quality
standards for export to USA, EU, EM and Domestic market.
REGULATORY FILINGS (API RAICHUR UNIT-1 & UNIT-2) FY- 2023-24
API |
|
|
|
|
|
Particulars |
Filed in 2023-24 |
Cumulative Filed |
Status |
Planning to file in 2024-25 |
Remarks |
US DMF |
No new DMF's were Filed |
44 DMF |
25 DMF was Approved 3 DMF was under review
16 DMF's CA listed |
15 molecules are planned for validation,
which includes on-going validation of 3 products. These molecules shall be ready for
filing. |
|
CEP-EDQM |
4 CEPs were Filed |
27 CEP |
19 CEP Approved 8 CEPs under review |
3 molecules are planned for file for CEP. |
|
EDMF |
4 ASMF were File |
30 ASMF |
24 ASMF was Approved 6 ASMF under review |
15 molecules are planned for validation,
which includes on-going validation of 3 products. Out of these 15 APIs, 3 are EP monograph
products and hence other 12 APIs may be filed in EU through ASMF procedures. |
|
Regulatory Inspections and approvals (API units) FY- 2023-24
Inspection By Regulatory Authorities |
Plant |
Remarks |
PMDA Japan |
API Unit- 2 (EOU) |
GMP approved |
COFEPRIS - Mexico |
API Unit-2 (EOU) |
GMP approved |
ANVISA-Brazil |
API Unit-2 (EOU) |
GMP approved |
REGULATORY FILINGS (FORMULATION UNIT) FY- 2023-24
Particulars |
Filed in FY 2023-24 |
Cumulative filed |
Cumulative Status |
Planning to file in FY 2024-25 |
Formulation |
|
|
|
|
US Submissions |
1 product submission |
30 Submissions |
13 - Final approvals |
12 Products |
|
|
|
3 - Tentative approvals |
|
|
|
|
14 - Under assessment |
|
EU Submissions |
4 New products Submissions |
30 Submissions (product wise) |
25- Final approvals |
30 Products |
|
|
|
5 - Under assessment |
|
Regulatory Inspections and approvals -Formulation Unit
S. No. Regulatory Agency |
Inspection date |
Status |
1. Kenya |
22.11.2021 to 23.11.2021 |
GMP Certificate received |
2. Kazakhstan GMP |
02.03.2022 & 04.03.2022 |
GMP Certificate received |
3. Nepal |
18.07.2022 |
GMP Certificate received |
4. Health Canada |
12.09.2022 to 16.09.2022 |
GMP certificate received |
5. TGA Australia |
19.09.2022 to 23.09.2022 |
GMP certificate received |
6. ANVISA (Brazil) |
28.08.2023 to 01.09.2023 |
GMP Certificate received |
7. Tanzania (TFDA) |
19.10.2023 to 20.10.2023 |
GMP Certificate awaited |
8. USFDA |
30.10.2023 to 09.11.2023 |
EIR Awaited |
9. Ukraine |
15.01.2024 to 20.01.2024 |
GMP Certificate received |
10. EUGMP Austria |
22.01.2024 to 26.01.2024 |
GMP Certificate received |
Regulatory Inspections and approvals- Unit-VII, ASD.
Regulatory Authorities |
Plant |
Date of Receipt EIR/Certification |
CDSCO and DCA |
Unit-VII, ASD |
June 22, 2021 |
DSIR |
Unit-VII, ASD |
May 24, 2022 |
DCA (Good Laboratory Practices) |
Unit-VII, ASD |
Sep 20, 2022 |
US FDA |
Unit-VII, ASD |
May, 2023 |
Ukraine GMP accreditation |
Unit-VII, ASD |
April 05, 2024 |
Regulatory inspections and approvals (Unit 6, Bangalore):
Inspection By Regulatory Authorities |
Plant |
Remarks |
Medicines and Healthcare products Regulatory Agency United
Kingdom (MHRA) ( UK ) |
Unit 6, Bangalore |
Certificate Of GMP Compliance Of A
Manufacturer since July 2022 |
Ministry Of Health , UAE |
Unit 6, Bangalore |
Manufacturing Site Registration Certificate
since Feb 2023 |
Therapeutic Goods Administration (TGA), Australia |
Unit 6, Bangalore |
TGA-e-business service Clearance since Dec
2023 |
SHILPA MEDICARE LIMITED INTELLECTUAL PROPERTY MANAGEMENT (IPM)
The Intellectual Property Rights (IPR) Department at Shilpa Medicare
Limited caters to Shilpa and its group companies. Our IPR department plays a critical role
in safeguarding the Company's innovations and creative works. Our team is dedicated to
managing and protecting our patents, trademarks, copyrights, trade secrets, and other
intellectual property assets. By doing so, we ensure that our competitive edge is
maintained and our brand integrity is upheld. Our IPR Department works closely with
R&D, legal, and marketing teams to develop strategies that align with our business
objectives and support our growth.
Key Responsibilities:
Patent Management: Overseeing the filing and maintenance of patents to
protect our technological advancements.
Trademark Protection: Ensuring our brand identifiers are registered and
defended against infringement.
IP Litigation: Handling disputes and litigation to defend our
intellectual property rights.
IP Strategy Development: Crafting policies and strategies to maximize
the value of our IP portfolio.
Highlights and Achievements FY 23-24:
Increased Patent Portfolio:
Successfully filed 9 new patents, taking the cumulative total to 563
patents and pending applications in India and other countries.
Shilpa received grant of 16 patents in India and other countries
including the US, Europe etc, expanding our global reach and protection.
Trademark Registrations:
Filed 9 new trademark applications and obtained registrations for 10
trademarks from Indian trademark office, enhancing our brand presence in India domestic
market.
Achieved a 100% success rate in defending against trademark
infringements.
Litigation Successes:
Successfully obtained an injunction against a domestic Indian Company
in relation to Shilpa's patent, which was issued and covers dispersible tablets of
Capecitabine.
Looking Ahead:
As we move forward, Shilpa remains committed to enhancing our IP
management capabilities and supporting the Company's strategic goals. We will continue to
focus on expanding our IP portfolio, leveraging our assets through strategic partnerships,
and maintaining rigorous enforcement of our rights. Our ongoing efforts will ensure that
Shilpa Medicare Limited and its group of companies remain at the forefront of innovation
and market leadership.
Shilpa Medicare Transdermal Patches & Oral Film Manufacturing Plant
(Unit VI)
A transdermal patch is a medicated adhesive patch that is placed on the
skin to deliver a specific dose of medication through the skin and into the bloodstream.
Transdermal patches have made their place in the global market in the past few decades as
an alternative to conventional therapeutic for various disease indications. Transdermal
patches are widely accepted among physicians and patients due to their non-invasive, pain
free and easy administration. In recent years, the growth of the transdermal patch market
has increased and is expected to increase significantly in coming years. Higher
investments in research and development could be attributed to the success of the
transdermal patch market.
Similarly, the oral thin film drugs were recorded with high market
acceptance due to its ease of application and high effectiveness. Moreover, developed
economies such as the U.S. and countries in Europe recorded significant sale of oral thin
film drugs. The oral thin film drugs achieve the desired therapeutic results. Therefore,
they have gained attention in the market as a potential treatment option.
Looking to the market potential, facility is designed and build a state
of art Manufacturing facility of Transdermal Patch and Oral Thin Films at Bangalore. This
facility shall cater to the Global Regulatory Market.
The layouts confirming cGMP requirements are finalized along with
Utility, Administration, and canteen building. The equipment's are designed to cater both
Transdermal Patch and Oral Thin Film Products. Space for future expansion is allocated for
capacity increment.
Transdermal System / Patch (TDS) and Oral Dispersible Film (ODF)
Manufacturing Plant status highlights:
Transdermal Patch and Oral Film Manufacturing Facility is a
Qualified GMP facility to manufacture exhibit batches filling product filling and
commercialized in Global market. This facility is approved by MHRA (UK) for ODF
products.
We have completed execution of Exhibit/filing batches of Ten
ODF products and one Transdermal product which includes strength wise 104s batches. We
have filed an ODF product in UK MHRA which is got approval in 2023. The rest of the
products are under Clinical studies and stability studies and will be ready to file for
different countries in the coming months.
We have got GMP certification program for Dietary Supplements
(ODF) from UL Verification Services Inc.; Pennsylvania 18106; United States of
America.
We have ISO 5001:2018, ISO45001:2018 and ISO 14001:2015
Certification from AQC Middle East LLC, Noida, U.P. India and ISO / IEC 27001:2013
Certification from KVQA Certification Services Pvt Ltd Delhi, India
We have Manufacturing Site Registration Certificate from Ministry
of Health, UAE
Site is approved by TGA Australia and Commercial Orders
from well known clients are in pipeline.
We have COPP/WHO Licence to manufacture for sale (or for
distribution of) drugs other than those specified in [Schedules C and C(l) and X]
We have many Nutraceutical ODF products / Sublingual film
products / TDS in the development pipeline which are close to scale up and at different
stage of development pipeline for Global market.
These ODF Products are filed in multiple regulated as well as
non-regulated markets and commercial agreements with multiple clients are in progress.
Transdermal product agreements with European clients is done,
product is under stability and filing is expected in end of 2024.
API Business Plan
Over the past decade, India has emerged as a key player in the API
sector, following regulatory shifts in China and subsequent disruptions in the global
chemicals supply chain. Benefiting from robust chemistry expertise and advantageous
business conditions such as competitive labor costs, adherence to environmental and safety
regulations, and international regulatory certifications, India's API industry has
garnered attention from global generic pharmaceutical companies.
The recent challenges in supply chains due to the Covid-19 pandemic and
resulting logistical hurdles have further solidified India's reputation as a dependable
source of APIs. In 2022, the global API industry was valued at approximately USD 222.4
billion, with projections suggesting a steady growth at a CAGR of around 6% from 2023 to
2030, reaching USD 353 billion by 2030. Merchant APIs are expected to account for 40% of
this market, with specialty small molecules representing close to 14% by value.
By FY25, domestic API consumption in India is anticipated to reach USD
21 billion. The growth of the API market can be attributed to advancements in
manufacturing capabilities, coupled with an increase in the prevalence of chronic diseases
such as cardiovascular ailments and cancer. Supportive government policies and changes in
geopolitical dynamics are also contributing to the industry's expansion.
Despite significant API imports from China, particularly antibiotics,
and China's dominance in export markets, global generic companies are adopting a
"China + 1" strategy, which is expected to boost exports. Simultaneously,
initiatives like backward integration and the Government's Production Linked Incentive
(PLI) scheme are likely to reduce reliance on imports and stimulate domestic production.
In 2023 globally CDMO business is valued around @ 146 billion dollars,
which is segregated across the globe, China is responsible for 27 billion dollars and
India @ 15.63 billion dollars. The opportunity is huge to act as a reliable, trustworthy
CDMO player.
Shilpa with its technological capabilities, process efficiencies, high
quality manufacturing standards and facilities meeting regulatory standards of all major
markets, occupies a sweet spot in the API and CDMO industry. With global spending on
treatment for cancer on the rise, Shilpa has a role to play in offering cost competitive
oncology APIs to the global generic industry and thereby try and reduce the cost for
patient treatment. The Company focusses on sustainable growth through continuous cost
reduction measures. With 9 dedicated oncology manufacturing blocks and multi product
capability, we are ready to meet the growing demand for oncology APIs.
While we continue to develop new oncology APIs to meet the demand for
off patent products, we are also now developing a range of non-oncology API molecules to
cater to the growing outsourcing demand from India. 8 production blocks cater to this
segment.
Shilpa is investing heavily on API R&D and augmenting its
capabilities across various API segments (Peptides, niche oncology, Intermediates). The
API business is expected to grow on account of increased capacity and backward integration
which will lead to operational efficiencies.
Leveraging on existing infrastructure and geopolitical situation Shilpa
has an incremental opportunity to support CDMO business. It needs to further strengthen
and R & D more competent. Develop state of art infrastructure for Drug Substance and
Drug Product.
Shilpa' s commercialization of Polymers and Peptides would also lead to
incremental revenues and offer a complete range of services in Generics and CDMO space.
Shilpa has the requisite approval from Health Authorities to sell APIs
in the regulated markets. With 21 valid CEP certifications and 45 active US DFMs and more
on the anvil, Shilpa is well poised to grow business in this segment of the market. A
strong pipeline of APIs at various stages of development will contribute to the growth of
business year on year. The Company maintains the most stringent quality standards for all
its products.
Our wide range of APIs, early entry opportunity for customers due to
non-infringing chemistry and supply security, will position Shilpa as a preferred partner
for API supplies. Our long-standing relationships with existing partners, whom we have
supported in establishing leading market positions, will help enhance our share of
business with them.
With a large number of products in Shilpa's API portfolio getting
genericized between 2025 and 2028, we expect business from commercialization of these
molecules to sustain our growth momentum. Attaining cost leadership, product
differentiation, backward integration, customer centric approach will form the pillars of
our business strategy.
US CDMO Business Plan Introduction
The Pharmaceutical Contract Development and Manufacturing Organization
(CDMO) market is estimated at USD 243.29 billion in 2024, and is expected to reach USD
331.98 billion by 2029, growing at a CAGR of 6.41% (Mordor Intelligence, 2024). The CDMO
market revenue in the largest market - United States - was valued at USD 54.21 billion in
2023 and expected to reach USD 68.32 billion by 2028, growing at a CAGR of 4.74% (Mordor
Intelligence, 2024).
Small molecule API development and manufacturing for novel chemical
entities (NCEs) are expected to be the dominant segments in the CDMO market with a revenue
share of ~50% in 2018. Large molecules, such as biologics, biosimilars, cell and gene
therapies, are expected to witness the fastest growth over the next 5 years. Among global
markets, North America will maintain the lead due to the presence of some of the largest
industry players, focus on innovative R&D into new treatments, increasing aging
population, prevalence of chronic conditions emergence of new diseases, as well as the
relative abundance of funding from venture capital for undertaking the high-risk novel
drug discovery research effort. High R&D costs, capacity and capability limitations
and specialized expertise - all major constraints within
pharma companies big and small - make CDMOs excellent external
innovation partners to sponsors for expediting the drug manufacturing process while
offering significant time, cost, and process efficiencies.
Shilpa Medicare Ltd. (SML) can expect rapid growth in the CDMO business
due to its high-quality workforce, cost advantage in research and development (R&D)
and manufacturing, and expertise across a range of industry verticals. In particular,
SML's capabilities in drug substance (small molecules and large molecules) development and
manufacturing, finished drug product development and manufacturing, as well as therapeutic
peptides, polymer science and performance materials, makes a compelling case for the
Company to become firmly established as a partner of choice for a wide range of companies
across pharma and non-pharma segments.
Market strategy
Shilpa Medicare is a fully integrated Company providing DS, DP
development and cGMP manufacturing from USFDA, Health Canada, EMA, PMDA, KFDA, Cofepris,
and TGA accredited facilities. It is therefore well positioned to become a trusted and
truly end-to-end solution provider given existing infrastructure and continuous capital-
intensive investments.
(1) Leveraging exquisite strengths in complex chemistry across pharma
and specialty chemicals
(2) Integrated CMC approach for delivering drug substance and drug
product to pharma customers
(3) Strengthening of biologics business with a focus on monoclonal
antibodies, fusion proteins and ADCs
(4) Technology focus with addition of niche capabilities such as flow
chemistry and AI-DD
As an external innovation partner to the innovator biopharma industry,
the Company bring differentiation at several levels that sets it apart in the CDMO
industry -
(1) Early phase to late phase from AI/ML led discovery (target to hit,
hit to lead and lead to NCE) to custom synthesis, scale up and clinical materials (for
advanced intermediates, RSMs)
(2) cGMP manufacturing with multi-metric ton commercial manufacturing
capacities for advanced intermediates, RSMs and final API, incl., oncology, high potent
(OEL Band 5) and cytotoxic compounds
(3) Flow technology with the ability to conduct asymmetric catalysis,
fluorinations, nitrations and a range of hazardous/complex chemistries
(4) Process intensification using custom printed reactors that offer
exceptional COGS benefits over commercial flow reactors
(5) AI/ML based process R&D that yields optimized ROS, higher
selectivity and purity, and reduction of unwanted by-products and impurities (e.g., NDMA)
In addition, Shilpa enjoys a unique position - on one hand - as a
pharma Company first by combining both commercial and regulatory experience with
successful registrations of >40 complex products globally incl., in the US and EU
markets. On the services side on the other hand its experience in route scouting,
synthetic chemistry, process and analytical development, ICH stability, product
formulation, manufacturing, fill-finish, labeling and packaging offers customers a truly
integrated approach to drug R&D. That combined with a structured program management
approach assures customers of full support and high-quality execution from lab to clinic
to market.
We will follow a fundamentally partnership driven approach to the
market with a focus on brand building, innovation, impeccable delivery, and long-term
supply chain assurance as the key pillars of customer engagement and success. We will
follow a Deep Science methodology based on deep know-how of clients' clinical pipelines,
chemistry and biology that will position Shilpa as a research driven CDMO and facilitate
the acquisition of net new logos. We will establish a Program Management approach to
delivery that transitions clients from a PO based practice to a full ownership and full
lifecycle model and assure Speed to Clinic and Speed to Market. We will create a
Pharmaceutical Sciences Platform that offers clients a full-value chain solution
incorporating integrated CMC and program delivery from lead selection to IND within 10-12
months where technical teams will work across functions to ensure knowledge retention from
early to late phase incl., scale up, clinical trial materials and cGMP manufacturing. We
will establish a Governance Framework to ensure tight integration with key stakeholders
(client sponsors, technical, clinical, quality, regulatory, commercial heads) with the
objective to evolve from a project-based into a long-term value- based partnership and
ensuring consistent delivery.
We will develop and execute consistent omnichannel (print and digital)
marketing campaigns to evangelize Company's capabilities (website, email, print and
video), incl., Japanese language messaging on LinkedIn and other social media channels. We
will utilize sales automation and analytics to derive actionable intel and insights on
markets and customers (e.g., dormant accounts, underserved territories, BD productivity
metrics, win/loss stats, and so on).
Focus areas for 2024 - 2025
(1) Small molecules: The US Food and Drug
Administration (USFDA) approved 53 new molecular entities (NMEs) in
2020, of which 40, or 75%, were small molecules. Accordingly, a major focus for the
Company will be to strengthen its position and penetration in this segment. Shilpa
provides a fully integrated CDMO services covering drug substance, drug product
development and cGMP manufacturing from our USFDA, Health Canada, EMA, PMDA and TGA
accredited facilities. Our expertise covers custom synthesis, chemical development,
clinical materials, scale-up and cGMP commercial scale production of advanced
intermediates, RSMs and API, incl., high potency, oncology and cytotoxic compounds. As
oncology specialists, we bring significant experience in the development and manufacturing
of tyrosine kinase inhibitors such as Axitinib, Dasatinib, Erlotinib, Imatinib,
Lenvatinib, Nilotinib, Pazopanib, Sorafenib, Sunitinib and others, and a portfolio of
anti-cancer compounds (e.g., Bortezomib, Cabazitaxel, Capecitabine, Decitabine,
Enzalutamide, Gemcitabine, Pomalidomide, Temozolomide, to name a few). With these unique
capabilities, the CDMO business has picked up a number of innovator biopharma companies in
its portfolio of clients and delivered successfully on complex programs.
(2) Large molecules: The global biologics market was estimated at
USD 511.04 billion in 2024 and is projected to hit USD 1,374.51 billion by 2033, growing
at a CAGR of 10.4% from 2024 to 2033 (Nova One Advisor report,2024). Rising burden of
cancer, genetic, neurological and autoimmune diseases and approval of novel biologic drugs
such as gene therapies, RNAi therapeutics, and antibody-drug conjugates as well as
advancements such as personalized medicine and companion diagnostics which allow for
targeted treatments, have increased the demand for biologic products (Grand View Research,
2024). Monoclonal antibodies account for the largest number of biologics approved.
Next-generation constructs such a bispecific antibodies, antibody fragments, radio-
immunotherapies, nanobodies, and antibody-drug conjugates are driving the growth of this
segment.
Shilpa Biologicals from its fully integrated facilities in Dharwad,
Karnataka, India provides drug substance and drug product development and manufacturing
for global markets. The facilities are fully equipped with state-of-the-art upstream and
downstream processing for mammalian and microbial systems for monoclonal antibodies
(MAbs), fusion proteins as well as adenoviral and AAV based gene therapies and vaccine
production. This includes three lines for mammalian cell culture with 3x1KL single use
bioreactors, 2x2KL single use bioreactors and 10L and 40L ATF systems along with three
filling lines incl., a high throughput line with capacities of 300u/m liquid vial fill
(for vaccines). In microbial fermentation, we have 2x independent trains with 2KL capacity
(for E.coli and Pichia pastoris) and a greenfield project of 220KL SS bioreactor capacity.
Notably, we provide the full complement of services from cell line / clone development,
and cGMP cell banking to manufacturing, fill/finish (in vials and PFS), packaging and
labeling -
(1) CHO cells for MAbs, fusion proteins, glycoproteins and subunit
vaccines
(2) HEK cells for adenoviruses and adeno- associated viruses
(3) Pichia pastoris for VLP, antigen and heterologous protein
production
(4) E. coli for DNA vaccines and high purity DNA plasmids (for mRNA
vaccines)
Our expertise stems from extensive hands-on development of molecules
such as recombinant human albumin, an NBE, biosimilars such as adalimumab, etanercept,
aflibercept and abatacept, as well as vaccine manufacturing (e.g., from HEK293 and E. coli
for Covid-19 and high purity DNA plasmids for mRNA vaccines). In addition, we have
developed recombinant human albumin (rHA) in-house as a superior substitute as compared to
what is available from natural sources such as plasma which carries risk of contamination
from biological agents and pathogens. Several companies have shown interest in a strategic
collaboration with us on rHA with immense commercial potential for the Company.
(3) Therapeutic peptides: The global peptide therapeutics market is
forecasted to exceed USD 101.7 billion by 2033, with a CAGR of 9.1% from 2024 to 2033
(Market.us, 2024). Peptide therapeutics consist of drugs composed of short or long chain
amino acid chains designed to target specific disease states and offer advantages over
small molecule drugs, such as high selectivity, specificity, low toxicity, and favorable
pharmacokinetics. Several peptide drugs have reached the market for diseases such as
cancer, multiple sclerosis, diabetes, osteoporosis, chronic pain, and HIV infection. This
is a high growth market due to advancements in peptide design technologies, incl., use of
bioinformatics and systematic biological approaches, rising R&D investments in
peptide-based therapies, and inherent favorable properties such as high specificity and
tolerability. Recent product approvals in this space include Semaglutide, the active
ingredient of blockbuster Novo Nordisk drugs Ozempic? and Wegovy?, for treatment of type
2 diabetes and long- term weight management. Semaglutide is a peptide similar to the
hormone glucagon-like peptide-1 (GLP-1), modified with a side chain.
Shilpa is extremely well positioned in this space given our proven
expertise in development, synthesis, incl., advanced technologies such as microwave
synthesis, and formulation of peptide products. The
Company completed a program in February 2023 for Genentech involving
complex macrocyclic peptides. In 2024, a reputed NYSE listed biopharma Company approached
us for development of a bispecific small molecule that binds the liver asialoglycoprotein
receptor on one hand and the target (IgG) on the other hand joined through a peptide
linker. This is an excellent opportunity for us to present our peptide synthesis, small
molecule development and manufacturing as well as bioconjugation expertise in the long
run. The client will be conducting an audit of the Raichur site at the end of May 2024.
(4) Polymers and performance materials: The global polymers market
was valued at USD 597.34 billion in 2022 and is expected to experience robust growth with
a projected CAGR of 4.81% through 2028 and is expected to reach at USD 785.80 billion by
2028 (Research and Markets, 2024). Shilpa brings specialized expertise in specialty
polymers from custom synthesis through a range of mechanisms, such as free radical
polymerization, ring-opening polymerization, anionic and cationic polymerization, ATRP
polymerization, RAFT polymerization, and condensation polymerization. We bring specialized
expertise in PEGylation chemistry (incl., high MW pegylations), application of
poly(butadiene)-b- poly(ethylene oxide) for controlled drug release as well as a range of
capabilities in development of derivatives (e.g., functionalization of polybutadienes, and
other polymers) and can deliver high quality and cost-effective products at any commercial
scale from our USFDA approved facilities. The polymer division has won a number of
programs and enjoys long- term relationships with several marquee customers in the polymer
space incl., such names as Bausch and Honeywell. The latter began as a modest R&D
project that met the specifications defined by client and became a larger initiative which
has the potential to become a multi-million dollar program in 2024-2025. Successful
deliveries with this Fortune 500 customer also means excellent potential for follow-on as
well as new projects.
(5) Antibody-drug conjugates (ADCs): The global antibody drug
conjugates market was estimated at USD 11.29 billion in 2023 and is projected to grow at a
CAGR of 9.2% from 2024 to 2030 (Grand View Research, 2024). This can be attributed to the
growing incidence of cancer, increased need for low-toxicity and effective drugs. An
increasing number of ADCs are entering clinical trials and our experience with handling
cytotoxic payloads, linker technologies, bioconjugation reactions and antibody
development, as well as large in-house manufacturing capacity and the required containment
and engineering controls - all under one roof - means we can quickly emerge as a front
runner in this space. Given their complexity, more than 70% of ADC projects are outsourced
to CDMOs and this is therefore another thrust area for the Company. In 2024, the Company
had interest from a marquee NYSE listed biopharma Company to conduct a site audit of the
Raichur facilities for potential qualification for development and manufacturing of ADCs.
This is a major achievement and an excellent opportunity to break into the ADC market
given significant business potential.
(6) Cell and gene therapies: The global cell therapy market size
was estimated at USD 4.74 billion in 2023 and is expected to grow at a CAGR of 22.66% from
2024 to 2030. The market for cell therapy is constantly growing to include new cell types,
which presents significant opportunities for companies to strengthen their market
positions. The growth of the market is attributed to many factors such as expanding area
of advanced therapies along with gene delivery technologies and progressive competition
among key players focused on commercialization of their therapies. Analysis of companies
going public or raising fresh capital indicates nearly 50% of the companies have small-
molecule pipelines while 20% are focused on monoclonal antibodies and recombinant proteins
and 20% are developing cell and gene therapies. So, while the focus will be on monetizing
our existing capabilities and infrastructure in small and large molecules, a future proof
strategy will include forward investments into new capabilities, especially in cellular
therapies.
(7) Drug Product Development: The Company brings decades of
experience developing a wide range of finished dose formulations, e.g., orals, injectables
(fill finish in vials and pre-filled syringes), ophthalmics, suspensions, topicals,
extended-release formats such as oral thin films and transdermal systems as well as
nanoparticle, liposomal and lyophilized preparations. This includes extensive experience
in developing value-added clinically differentiated 505(b)(2) products across therapy
areas that enhance the patient experience. We have successfully registered >50 products
globally incl., in the US and EU markets and bring together synthetic chemistry, process
development, manufacturing and regulatory expertise assisted with AI/ML enabled discovery
and development for a uniquely integrated CMC approach to drug R&D. The Company has
successfully delivered on drug substance and drug product programs under its CDMO business
for US based biotech companies following this approach.
SML is extremely well positioned because of these superlative and cross
value chain capabilities to become a strong contender for innovative solutioning across
modalities to the biopharma, polymer and chemicals industry globally.
Domestic
At Shilpa Medicare Ltd as our key expertise lies in the oncology
formulation this Fiscal Year 2023-2024, we have embarked on our journey to reach out to
all the cancer treatment facilities nationwide with the primary goal of offering
World-Class drugs at competitive pricing, with innovation and affordability to ensure the
patient compliance and reduced drug wastage.
By employing the most capable field teams with the best abilities and
providing them with the most up-to- date scientific knowledge on treatments and products.
In the year 2023-2024, we have expanded our reach to guarantee that the most recent
scientific advancements may be disseminated to all Stakeholders, particularly the medical
community and caregivers.
At Shilpa Medicare Ltd. (OnKoshil division), patients are at the
heart of all we do. With the Mantra of "Thoughtful Innovation for Powerful
Outcome," we have produced distinctive Products.
Capebel Dispersible Tablet (Capecitabine 500mg& 1000 mg dispersible
tablet) is a great example. Capebel DT enabled clinicians to deliver appropriate doses
with more compliance, resulting in a more potent outcome for over 4000 patients in the
last Fiscal Year 23-24.
Along with Capebel DT, Lenshil 12mg & 18mg, Oraal Spray and VRTU
(Ready to Use pemetrexed Inj) were the classical examples of Shilpa Medicare's approach
towards Thoughtful Innovation for Powerful Outcome
Current market trends:
Globally, today India is one of the largest sources of Pharmaceuticals,
and Shilpa Medicare Ltd has been one of the strongest API sources for Oncology Products.
In India, an estimated 1.41 million new cancer cases are diagnosed each
year with 0.9 million deaths annually, Since the last decade, the cancer burden has more
than doubled in India. Breast, Lip, Oral, and Cervical Cancer account for 1/3rd of cancer
cases in India. 5-year prevalence is estimated to be around 3.26 million Patients. A
recent survey entitled INDIA as the Cancer Capital gives us more responsibility to develop
the products and serve the needy.
The domestic oncology market is valued at C7212 Cr and growing at a 21%
rate across the range of medicines including hematology and solid tumors. Immunotherapies
and Targeted MABs are therapeutic oncology subspecialties that are expanding quickly.
Additionally, the new molecular pipeline into the domestic market offers doctors
additional possibilities for interventional therapy and new paths for patients needing
treatment assistance.
Oncology has a high demand for therapies, making improved formulation
with a patient-centric approach even more critical. Shilpa Medicare Ltd is
therefore obligated to offer such Thoughtful Innovations for Powerful Outcomes.
Strategic Brand Launches into various therapies with futuristic potential and untouched
areas. ONKOSHIL is entering the new therapeutical area of Targeted therapies.
Ca Prostate therapy - Launched Leuprolide 22.5mg and Relugolix
120mg in treating Cancer of the Prostate, developing a strong portfolio in the therapy.
Breast Cancer- Ready to launch OLAPARIB, a well- accepted PARPi in
the treatment of Breast and Ovarian Cancers - Targeted Therapy.
Supportive Therapy: Iron replacement products like Ferric Carboxy
Maltose, and erythropoietin stimulating agent like Darbepoetin.
Cytotoxins with compliance (Ready to Use formulation)
- Ready to use a 10-minute infusion of Pemetrexed for the first
time globally, with unique formulations of 100mg, 500mg 850mg, and 1000mg.
To effectively maximize the benefits of Thoughtful Innovations for
Powerful Outcomes, frequent communication aids and performing RTM and CME with doctors
and emerging experts are required to effectively reach this communication with the
caregivers, and our field force is fully equipped on this front.
Product Reach to the Customers: Product Inclusions into the
Formulations of major institutions, which multiply the consumption and provide spread of
the brands. Few of the centers where the products are approved.
TATA Memorial Cancer Hospital, KMSCL(Kerala), RAILWAY Hospitals,
Command Hospitals, Safdarjung Hospitals (Delhi).
Strategic Growth Factors:
The growth for the next Fiscal is protected with the inclusion of the
differentiative formulations into the institutional formulary helps in product awarding
and continuous business outcomes,
Unique formulations can have the advantage of monopoly in the formulary
and can serve the needs of the needy with the provided advantage of reducing the drug
wastage and improving compliance etc.
Registering & making products available at various corporate
hospitals to enhance the business & reach across the country. Key account management
(customers) and ensure patient follow-up to develop the base.
Recent Trends including pricing in Oncology and Approach:
In the oncology market, new molecules are introduced quickly due to
patent expirations. Prices are extremely volatile because of the constant introductions of
the same molecules by different companies, but special dosage forms & like
Capecitabine DT must be developed with the patient in mind. Decreasing medicine wastage by
developing Multidose Ready to Use [RTU] formulations, especially injectables like VRTU.
Effectively communicating the same with regular communication aids and
engagements with doctors and emerging specialists is the key to improving the reach of
innovations to needy humans.
Strong Growth in Biologic & Biosimilars Drugs in Domestic Market:
The Indian biopharmaceutical industry is one of the fastest growing
globally and currently valued at US $60 billion. The country's biosimilars market size was
valued at US $349 million (C 2800 Cr) in 2022 and is estimated to expand at a CAGR of
25.2% from 2022 to 2030 to reach US $2.1 billion (C17500 Cr) in 2030.
There are 98 approved biosimilars in India, with at least 50 on the
market, the most of any country in the world. Between now and 2030, biologic products
worth some $170 billion will lose patent protection, opening the window of opportunity for
Indian biopharma to explore more biosimilar products.
With plethora of opportunities, Shilpa with its very own entity Shilpa
Biologics Pvt. Ltd, Dharwad has indigenously manufactured and introduced the Original
OriAdali (Adalimumab 40mg/0.4ml concentration) in FY 23-24. Shilpa Biosciences - OriAdali
is similar to the reference product in quality, safety & efficacy. Indian adalimumab
market is valued at C122 Cr market with CAGR 26% (Source: IQVIA) and with launch in just 6
months we have achieved 1% market share.
Shilpa Biosciences, division of SBPL has a vision to reach & serve
comprehensive basket for management of Rheumatoid Arthritis (RA) Osteoporosis (OP),
Osteoarthritis (OsA) Inflammatory bowel disease (IBD) & Psoriatic Arthritis (PsA).
Shilpa Biosciences has also launch of Denosumab (Denosta) &
Teriperatide (Bone PTH) for Osteoporosis management which has further enhanced our
presence in the biologics - biosimilar market. Osteoporosis market valued at H466 Cr with
CAGR 43%. We have captured 1.30% MS in 1st year of launch. Shilpa Biosciences, at SBPL
presence is being felt in market and we have been taken as one of the serious
biologic-biosimilar player wherein we have to compete with biologic giants.
Shilpa Biosciences at SBPL, is currently operating in H 693 Cr
biologics market with CAGR 34%. IN FY 23-24 we have achieved 1.15% MS of our represented
market. Our vision is to attain 7% of MS in first three years of launch.
We have a goal to become one stop solution for the comprehensive
management of Rheumatoid Arthritis & Osteoporosis in times to come. We at Shilpa
Biosciences at SBPL aim to spread our reach and become one of the strong
biologic-biosimilar player in the market.
Shilpa Biologicals Pvt Ltd Introduction
Shilpa Biologicals Pvt Ltd (SBPL) specializes in the development of
biologics and has prioritized obtaining approvals and market authorizations for internal
projects while expanding its CDMO capabilities. The Company's relentless focus on quality
control and assurance underscores its dedication to meeting regulatory standards and
delivering superior products and services to its clients and partners.
Biosimilar Programs
SBPL's biosimilar programs for Adalimumab, Aflibercept, Abatacept,
Pembrolizumab and Nivolumab, have made significant progress towards global regulatory
filing. The strategic focus on obtaining approvals from different markets underscores
SBPL's commitment to expanding its global reach and addressing the needs of patients
across diverse regions.
Oriadali? Launch:
The SBPL's has launched biosimilar to Humira, Oriadali?, in India
during the 1st quarter of 2023-2024 marks a significant milestone for the organization.
SBPL's Adalimumab is distinguished as one of the very few biosimilar versions of the innovator's
high-concentration product (100mg/mL), offering a cost-effective alternative without
compromising quality or efficacy.
Expanding the use of Oriadali? for different indications represents a
strategic opportunity for SBPL to further capitalize on its investment in biologics
development. By leveraging Oriadali?'s proven efficacy and safety profile, SBPL can
explore additional therapeutic areas where anti- TNFa therapy is indicated.
By pursuing regulatory approvals for Oriadali? in these additional
indications, SBPL can maximize the commercial potential of its biosimilar while
contributing to improved patient outcomes across a diverse range of medical conditions.
Furthermore, expanding Oriadali?'s indication portfolio aligns with SBPL's commitment to
innovation and addressing unmet medical needs, further solidifying its position as a key
player in the biopharmaceutical industry.
Clinical Trials and Pipeline Expansion:
SBPL is currently taking clinical trial batches of biosimilar to Eylea
and planning to initiate the phase III clinical trial in Q2 of FY25, demonstrating its
commitment to innovation and patient care in ophthalmology. Additionally, the Company has
expanded its pipeline with additional three pipeline drugs which are at different
developmental stages, from process optimization to preclinical studies, showcasing SBPL's
dedication to research and development.
CDMO Capabilities and Strategic Expansion:
SBPL has strategically expanded its operations to offer comprehensive
Contract Development and Manufacturing Organization (CDMO) services to pharmaceutical and
biotechnology companies worldwide. SBPL's CDMO division leverages the Company's extensive
expertise in biologics development, manufacturing, and quality assurance to provide
end-to-end solutions tailored to meet the diverse needs of its clients.
Comprehensive Service Offerings:
SBPL's CDMO capabilities encompass a wide range of services spanning
the entire drug development and manufacturing lifecycle. These include:
1. Process Development: SBPL's team of experienced scientists and
engineers collaborate closely with clients to develop robust and scalable manufacturing
processes tailored to their specific requirements. From cell line development to process
optimization and scale-up, SBPL offers comprehensive process development services to
accelerate the path to commercialization.
2. Analytical Method Development and Validation:
SBPL's state-of-the-art analytical laboratories are equipped with
advanced instrumentation and expertise to develop and validate analytical methods for
product characterization, quality control, and stability testing. By ensuring the
accuracy, precision, and reliability of analytical data, SBPL enables clients to meet
regulatory requirements and ensure product quality.
3. Manufacturing: SBPL operates cGMP-compliant manufacturing
facilities equipped with cutting-edge bioprocessing technologies to produce biologics at
various scales. Whether it's microbial fermentation, mammalian cell culture, or downstream
purification, SBPL's manufacturing capabilities are designed to deliver high-quality,
cost-effective solutions to meet client demand.
4. Quality Assurance and Regulatory Compliance:
SBPL places a strong emphasis on quality control and assurance
throughout its CDMO operations. Its quality management system is aligned with
international regulatory standards, ensuring compliance with Good Manufacturing Practices
(GMP) and other regulatory requirements. SBPL's dedicated quality assurance team monitors
all stages of the manufacturing process to ensure product quality, safety, and efficacy.
Strategic Partnerships and Collaborations:
SBPL actively seeks strategic partnerships and collaborations with
pharmaceutical and biotechnology companies to leverage its CDMO capabilities and expand
its market presence. By offering flexible and customized solutions, SBPL aims to address
the evolving needs of its clients and provide value-added services that contribute to
their success.
Recent Achievements and Future Outlook:
In the current year, SBPL's CDMO division has witnessed remarkable
growth and achievement, marked by the expansion of its client base and service portfolio.
Through successful project executions and unwavering dedication to quality and innovation,
SBPL has emerged as a trusted partner in the global biopharmaceutical landscape. With a
commitment to excellence, SBPL continues to lead the industry, offering tailored solutions
to meet the evolving needs of clients both domestically and internationally.
Regulatory Approvals and Inspections:
SBPL achieved joint inspections and clearance from the Central Drugs
Standard Control Organization (CDSCO) for marketing authorization of its Biosimilar to
Humira and Bioanalytical Laboratory. These achievements not only facilitate clinical trial
programs but also open new avenues for revenue generation through contract research
organization (CRO) activities.
Positive Scientific Advice from the FDA & EMA:
SBPL is pleased to announce that we have received positive feedback
from the FDA and EMA regarding our CMC package and clinical trial proposals for
Aflibercept. This validation from regulatory experts reinforces the robustness and
efficacy of our development strategies, positioning us for success in obtaining regulatory
approvals for the biosimilar products in the regulatory market. Building on the positive
feedback received from the EMA, SBPL remains focused on advancing the development of
Aflibercept while maintaining the highest standards of quality and compliance.
Conclusion:
In conclusion, the achievements of Shilpa Biologicals Pvt Ltd in the
fiscal year 2023-2024 underscore its position as a leader in the biopharmaceutical sector.
Through strategic initiatives, relentless focus on quality, and dedication
to innovation, SBPL is poised for sustained growth and success in the
years to come.
FTF PHARMA (P) LTD
The journey started in 2012 for FTF Pharma has been unstoppable'
and continued to leave its footprints worldwide. FTF Pharma is not a new name in the
pharmaceutical world. It has achieved a special reputation' milestone over these
years, which is evident from the fact that yearly it adds many new clients to its
clientele list.
When a dream was seen to become a CDO/CDMO of every partner's choice,
the Company was started with very limited resources, infrastructure and manpower. However,
steadfastly moving towards its mission, in very short span FTF Pharma grew to a level
where it now owns a 55,000 sq. ft. state-of-the-art R&D center with modern & well
equipped formulation & analytical research labs and facility for handling highly
potent drugs situated in the hub of India's Pharmaceutical giants, Ahmedabad (Gujarat).
Over 70 scientists are striving day and night to help FTF Pharma achieve its mission of
becoming globally leading player in the Contract Research sector. FTF is a one stop
solution for its partners. FTF offers Research and Formulation Development services,
Technology Transfer & Contract Manufacturing services, Non-infringing/ Design-around
strategies, Regulatory filing strategies, and BA/BE & clinical support services.
Visioned to provide the best and most affordable healthcare, FTF is
focused on the development of high valuedfirst-to-file generic products
underANDAregulatory pathway, complex generic products & innovative new drug products
covered by 505b2 NDA applications. FTF eyes its interest on the development of small
molecule drug products & peptide drug products as well as repurposing of existing
drugs. Since its inception, FTF, so far, has developed & collaborated more than 120
products for major regulated markets & rest of the world markets.
FTF has an expertise of developing different types of solid, liquid,
lyophilized & topical dosage forms. These dosage forms include tablets, hard gel
capsules, low & high volume parenterals (ready-to-use/dilute solutions, suspensions),
lyophilized solids, oral thin films, strips, patches, prefilled syringes, ophthalmic
solution & drops, coated/uncoated/sugar coated/film coated pellets/beads in capsules,
matrix dosage forms, orally disintegrating tablets, IR/ER/PR/SR/DR/MR dosage forms,
bi-layered tablets, and combination products. So far, coming age technologies in the
pharmaceutical development are concerned, FTF is not lacking behind. FTF is also working
on new-edge technologies such as Nano-emulsions, SMEDDS, micellar formulations and lipid
nanoparticles.
Success is not a dream' for FTF Pharma but a reality. The drug
products developed by FTF Pharma are now approved by the world's some of the major
regulated markets such as US and UK. These products include first to file generics of
Aubagio?, Opsumit? and Otezla?; 505b2 oral liquids such as Norliqva? (amlodipine oral
solution), Tadliq? (tadalafil oral suspension), Zonisade? (zonisamide oral suspension),
Liqrev? (sildenafil oral suspension), Atorvaliq? (atorvastatin oral suspension),
Myhibbin? (mycophenolate mofetil oral suspension) and oral solution of Imatinib mesylate;
and a ready-to- use Pemetrexed injection against Alimta? powder for reconstitution under
505b2 NDA approval pathway. These products are now in the market and have met the needs
and benefited thousands of patients.
FTF's approach towards drug development through innovation is evident
from its Intellectual Property filings. FTF has filed more than 110 patent applications in
different jurisdictions including USA, Europe/UK, Canada, China, and India and awarded
multiple US & Indian patents covering FTF's 505b2 oral & parenteral technologies.
It's been about 4 years now that FTF has been spearheaded by Shilpa
Medicare Limited Group (SML) and achieved new milestones by penetrating the US, Europe,
Canada, China and other emerging markets. Now it can be foreseen that FTF is not away from
its vision of becoming one of the TOP GLOBAL CROs by 2025.
Shilpa Therapeutics Pvt. Ltd (formerly NU Therapeutics Pvt. Ltd.)
Situated at Cherlapally, IDA Phase-III, Medchal-Malkajgiri District,
Hyderabad, Telangana, India - 500051, a progressive novel drug delivery Company with an
international outlook is dedicated to the development and commercialization of innovative
and patient compliant novel drug delivery systems such as fast disintegrating oral strips.
*Shilpa Therapeutics Pvt. Ltd.(formerlyNUTherapeutics Pvt. Ltd.) is the
first Company to commercialize prescription products as oral thin strips/films in
India.
The plant has recently Upgraded to carter Regulated Markets like ROW
and European countries and the products are being updated to cater the registration
requirements of the respective countries.
Products available in the Domestic Market
Shilpa Therapeutics had obtained manufacturing and marketing
license from the Drugs Control General (India), New Delhi for the following products and
these products have also been launched in India by well-established national
pharmaceutical companies.
Molecule |
Category |
Ondansetron Hydrochloride 2mg , 4mg & 8mg Orally
Disintegrating Strips |
For the prevention of chemotherapy induced nausea and
vomiting (CINV) |
Simethicone 62.5mg Orally Disintegrating Strips |
Anti-Flatulent. |
Sildenafil Citrate 25mg & 50mg Orally Disintegrating
Strips |
For the treatment of erectile dysfunction (ED) |
Tadalafil 5 mg, 10mg & 20mg Orally Disintegrating Strips |
For the treatment of erectile dysfunction (ED) |
Methylcobalamin 1500 mcg Orally Disintegrating Strips |
For the treatment of Diabetic Neuropathy and Peripheral
Neuropathy |
Montelukast Sodium 4 mg, 5 mg & 10 mg Orally
Disintegrating Strips |
For the Prophylaxis and Chronic Asthama |
Melatonin 3 mg Orally Disintegrating Strips |
For the treatment Jet Lag |
Vitamin D3 2000 IU Orally Disintegrating strips |
Vitamin D3 Supplement |
Betahistine Dihydrochloride 16mg & 24 mg Orally
Disintegrating Strips |
For the treatment of Menier's syndrome characterised by
unilateral or bilateral Vertigo, sensorineural hearing loss. |
Green Tea Film - Ready to Prepare Green Tea |
For Household drink for therapeutic benefits. |
Menthol Mouth Freshener in different flavour |
Mouth Fresheners |
Paracetamol 60 mg & 120 mg Orally Disintegrating Strips |
For Paediatric Pain Reliever and a Fever Reducer. |
Prucalopride 1mg & 2 mg Orally Disintegrating Strips |
For Treatment of Chronic Constipation |
2 - Deoxy D Glucose Powder Dosage Form |
Adjunct Therapy for Moderate to Severe Covid 19 patients |
Products in the Pipeline
The following formulations are under various stages of Research &
Product Development along with several others in the initiation phase.
Molecule |
Category |
Rizatriptan 10 mg Orally Disintegrating Strips |
For Treatment of Migraine |
Methylcobalamin 1500 mcg + Pregablin 75 mg Orally |
For Treatment of Pain and for Diabetic and Peripheral |
Disintegrating Strips |
Neuropathy |
Pregabalin 25 mg/ 50 mg/ 75 mg ODS |
For Treatment of Pain |
Ketorolac Tromethamine 10mg ODS |
Anti - Inflammatory |
Strong Intellectual Property Management Team /Profile
Shilpa Therapeutics (formerly NU Therapeutics) has a strong IP profile.
The Company has been granted several patents on orally disintegrating strips
A state-of-the-art R&D center for developing oral strips and
sublingual film products, works in co-ordination with the Intellectual Property Management
team to develop cost effective generics and novel patentable formulations.
Patent filing statistics:
Total Filed : 35
Total Granted : 5
STPL to continue aggressive patent filings and protection of IP in
India and other important geographies of the world and plan to monetize the same.
STPL will continue to build its future pipeline of innovative and
"first-time-in-the-world" fast dissolving films with Intellectual Property (IP)
advantages and we are confident that the overall result of our initiatives will be evident
in the coming years.
Regulatory Approvals
ShilpaTherapeuticsPvt Ltd (formerlyNUTherapeutics) has received
approval for its oral disintegrating strip facility from following regulatory authorities:
National Pharmaceutical Regulatory Agency (NPRA) Malaysia, which
is an PIC/S member (Pharmaceutical Inspection Co- operation Scheme)
Ministry of Health Thailand'
Tanzania Medicines and Medical Devices
Pharmacy Poison Board - Kenya
National Drug Authority - Uganda
Regulatory Authority of DR Congo
Supreme Board Of Yemen
Regulatory Authority Cambodia
Many of the products are under screening process in above Ministries of
Health and are in verge of the products approval.
STANDALONE AND CONSOLIDATED FINANCIAL STATEMENTS:
The Standalone and Consolidated Financial Statements of your Company
have been prepared in accordance with Indian Accounting Standards (Ind AS') notified
under the Companies (Indian Accounting Standards) Rules, 2015, as amended.
Further, a statement containing the salient features of the Financial
Statements of our subsidiaries pursuant to subsection 3 of Section 129 of the Companies
Act, 2013 in the prescribed form AOC-1 is appended as Annexure to the Board's
Report. The Statement also provides the details of performance and financial position of
each of the subsidiaries.
SUBSIDIARIES, ASSOCIATES & JOINT VENTURES
The Company has direct and step down subsidiaries in India and
overseas. Consolidated financial statements have been prepared by the Company in
accordance with the requirements of Ind AS 27 issued by Institute of Chartered Accountants
of India (ICAI) and as per the provisions of the Companies Act, 2013 ("the
Act").
As per the provisions of Section 136 of the Act, separate audited
financial statements of subsidiaries are placed by the Company on its website at
www.vbshilpa.com. Statement containing the salient features of the financial statement of
subsidiaries and associate Company for the year ending March 31, 2023 in Form AOC-1
CHANGE IN THE NATURE OF BUSINESS
During the year under review, there was no change in the nature of
business carried out by your Company.
RAISING OF FUNDS THROUGH QUALIFIED INSTITUTIONAL PLACEMENT:
The Board of Directors of the Company at its meeting held on February
08, 2024 approved raising of funds for an amount not exceeding H 500 Crores through
Qualified Institutional Placement route. The Shareholders' of the Company passed Special
Resolution by way of postal ballot on 14th March 2024 to approve the raising of funds
through QIP.
The Company submitted Preliminary Placement Documents and Placement
Document to National Stock Exchange of India Limited and BSE Limited ("Stock
Exchanges") on 8th April 2024. Subsequent to which receipt of In-Principle approval
from the Stock Exchanges on 8th April 2024, the Board of Directors at its meeting held on
April 13, 2024 approved the issue and allotment of 1,09,89,010 Equity Shares of face value
T1 each to eligible qualified institutional buyers at the issue price of T455 per Equity
Share, i.e., at a premium of T454 per Equity Share (which includes a discount of T22.33
per Equity Share (4.68% of the floor price) to the floor price of T477.33 per Equity
Share, aggregating to T 4,99,99,99,550 (Rupees Four Hundred and Ninety Nine Crores Ninety
Nine Lakhs Ninety Nine Thousand Five Hundred Fifty only).. Consequently, the Promoter
Shareholding in the Company stands decreased from 50.01% to 44.39% whereas the Public
shareholding increased from 49.99% to 55.61% w.e.f. April 13, 2024 .
DIVIDEND:
In pursuance to the Dividend Distribution policy of the Company, your
Directors do not recommend any dividend for the year. The Dividend Distribution Policy of
the Company is set out as Annexure-2 and the same is uploaded on the Company's
website at https:// www.vbshilpa.com/pdf/Dividend%20Distribution%20PolicyUpdate.pdf
SHARE CAPITAL:
The paid up share capital of your Company is H 9,77,90,908/- (Rupees
Nine Crore Seventy Seven Lakhs Ninety Thousand Nine hundred and Eight) divided into
9,77,90,908 equity shares of H 1/- each.
Pursuant to the provisions of section 124 (5) of the Companies Act,
2013 read with the IEPF Rules, the Company has transferred 8214 shares, belonging to the
shareholders who did not continuously claim dividend for seven years from the financial
year 2016- 17 to IEPF Account, the details of which are placed on the website of the
Company.
LISTING OF EQUITY SHARES:
The securities of the Company are listed on National Stock Exchange of
India Limited (NSE) and BSE Limited (BSE). Further, the Company has no equity shares
carrying differential rights.
TRANSFER TO RESERVES:
During the financial year under review, your Company has not
transferred any amount to the general reserve.
DIRECTORS OR KEY MANAGERIAL PERSONNEL:
Mr. Omprakash Inani (DIN No.01301385), Non-Executive Director will
retire by rotation at the ensuing Annual General Meeting and being eligible, offers
himself for re-appointment.
CHANGE IN DIRECTORSHIP
During the year there were no changes in the Directorship.
Mr. Hetal Madhukant Gandhi & Mr. Arvind Vasudeva were appointed as
Independent Directors for a period of 3 yrs in the 34th AGM held on 28th September 2021,
effective upto the conclusion of the AGM to be held in 2024.
Members in the 32nd AGM held on 20th September 2019 reappointed Mr.
Vishnukant C Bhutada as Managing Director for a period of 5 years effective from 1st
October 2019. In 2022, Mr. Bhutada was also appointed as Managing Director of Shilpa
Pharma Lifesciences Ltd, a material subsidiary on a remuneration of H 3.50cr as minimum
remuneration in case of inadequacy of profits from Shilpa Medicare Ltd and remuneration in
excess of 5% on the net profits of Shilpa Pharma Lifesciences Ltd, with an overall
remuneration not exceeding H 15.00cr p.a for reminder of the tenure.
Since tenure of the Directors is due for completion, except Mr. Arvind
Vasudeva who did not express his willingness to continue, their reappointment sought is
subject to the approval of members of the Company at the ensuing Annual General Meeting.
CHANGE IN KEY MANAGERIAL PERSONNEL
There were no changes in the Key Managerial Personnel during the year.
Following are the key managerial personnel of the Company:
Mr. Vishnukant C Bhutada - Managing Director
Mr. Kalakota Sharath Reddy - Whole-time Director
Mr. Alpesh M Dalal - Chief Financial Officer
Mrs. Ritu Tiwary - Company Secretary & Complian ce Off icer
NUMBER OF MEETINGS OF THE BOARD:
During the financial year, Seven Board Meetings were held as detailed
below which are in compliance with the provisions of the Companies Act, 2013, the Listing
Regulations and Secretarial Standards on Board meeting:
1. 25 May 2023
2. 23 June 2023
3. 21 July 2023
4. 10 August 2023
5. 1 September 2023
6. 10 November 2023
7. 8 February 2024
STATEMENT OF DECLARATION GIVEN BY INDEPENDENT DIRECTORS UNDER SUB-
SECTION (6) OF SECTION 149:
The Independent Directors have submitted their declaration of
Independence, as required under Section 149(7) of the Companies Act, 2013 stating that
they meet the criteria of independence as provided in Section 149(6) and Regulation 25 of
SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
AUDITORS:
Statutory Auditors:
Members of the Company at the Annual General Meeting held on 28
September 2022 approved the appointment of M/s. Bohara Bhandari Bung And Associates LLP,
Chartered Accountants, Raichur FRN:008127S/S200013, as the new statutory auditors of the
Company to hold office for one term of 5 years commencing from conclusion of the ensuing
35th Annual General Meeting up to the 40th Annual General Meeting of the Company.
Cost Auditors:
The Board, on the recommendation of the Audit Committee, has appointed
M/s. V.J. Talati & Co., Cost Accountants, for conducting the audit of cost records of
various segments of the Company for the financial year 2024-25. As required under Section
148 of the Companies Act, 2013 and Rule 14 of the Companies (Audit and Auditors) Rules,
2014, a resolution is being placed at the ensuing Annual General Meeting for ratification
of remuneration payable to the said Cost Auditors.
Secretarial Auditors:
Mr. D.S. Rao, Practicing Company Secretary was appointed to conduct the
Secretarial Audit of the Company for the financial year 2023-24, as required under Section
204 of the Companies Act, 2013 and Rule 9 framed thereunder. The Secretarial Audit Report,
in form MR-3, for the financial year 2023-24 forms part of this Report as Annexure - 3.
The Board on the recommendation of the Audit Committee has appointed
Mr. D S Rao, Practicing Company Secretaries, as Secretarial Auditors of the Company for
the financial year 2024-25.
Internal Auditor:
Pursuant to the provisions of section 138 of the Companies Act, 2013
and rules made thereunder, the Board on the recommendation of the Audit Committee has
appointed M/s BDO India LLP as Internal Auditors of the Company for the financial year
2024-25.
COMMENTS BY THE BOARD ON EVERY QUALIFICATION, RESERVATION OR ADVERSE
REMARK OR DISCLAIMERS:
Statutory Auditors:
As there is no qualification, reservation or adverse remark in the
reports given by the Statutory Auditors, your directors need not provide any clarification
on the same.
Secretarial Auditors:
As there is no qualification, reservation or adverse remark in the
reports given by the Secretarial Auditors, your directors need not provide any
clarification on the same.
CONSERVATION OF ENERGY, TECHNOLOGY ABSORPTION, FOREIGN EXCHANGE OUTGO:
Information required under section 134(3)(m) of the Companies Act, 2013
read with Rule 8 of the Companies (Accounts) Rules, 2014, is enclosed herewith as Annexure
- 4
RISK MANAGEMENT POLICY:
Pursuant to Regulation 21(4) of SEBI (LODR) Regulations, 2015, the
Board of Directors have formulated and implemented a Risk Management Policy, which
identifies various elements of risks, which, in its opinion, may threaten the existence of
the Company and contains measures to mitigate the same. The Risk Management Policy of the
Company is hosted on the Company's website: www.vbshilpa.com.
A Risk Management Committee has been constituted as per the terms of
Regulation 21 of SEBI (LODR) Regulations, 2015 to monitor and review the major risks faced
by and the risk management plan of the Company periodically.
During the year two Risk Management Committee meetings were held on 16
September 2023 & 13 March 2024.
CORPORATE SOCIAL RESPONSIBILITY (CSR) POLICY:
In terms of the provisions of Section 135 read with Schedule VII to the
Companies Act, 2013 and the Companies (Corporate Social Responsibility Policy) Rules,
2014, a Corporate Social Responsibility Policy (CSR Policy), indicating the activities to
be undertaken by the Company, as framed by the Corporate Social Responsibility Committee
(CSR Committee) has been adopted by the Board of Directors. Accordingly, the Company has
transferred the CSR amount to Shilpa Foundation', a public charitable trust taking
up various social public causes of the society in and around Raichur, Karnataka and the
activities of the said trust are covered under the Schedule VII of the Companies Act,
2013. A report on the CSR activities, as required under Rule 8 of the Companies (Corporate
Social Responsibility) Rules, 2014, is enclosed herewith as Annexure - 5.
The Company has constituted the CSR Committee for monitoring the
activities undertaken by the Company in this regard. The CSR Policy of the Company and
other details as required is are placed on the Company's website at
https://www.vbshilpa.com/pdf/Nomination RemunerationPolicy.pdf
A Committee of the Board named as "Nomination and Remuneration
Committee" has been constituted to comply with the provisions of Section 178,
Schedule IV of the Companies Act and Regulation 19 of SEBI (LODR) Regulations, 2015. It
has been entrusted with the task to recommend to the Company the prospective Directors and
KMP who possess the requisite skills and positive attributes as specified in the
Nomination and Remuneration Policy.
The Nomination and Remuneration Committee has formulated a Nomination
and Remuneration Policy which recommends the guidelines based on which the annual
performance of the Independent Directors, Board and Individual Directors is carried out by
the Board.
The Nomination and Remuneration Policy of the Company is placed on the
Company's website at https://www.vbshilpa.com/pdf/NominationRemunerationPolicy.pdf
FORMAL ANNUAL EVALUATION MADE BY THE BOARD OF ITS OWN PERFORMANCE AND
OF ITS COMMITTEES AND INDIVIDUAL DIRECTORS:
The Board of Directors have carried out an annual evaluation of its own
performance, as well as that of its Committees and individual directors pursuant to the
provisions of the Sections 134 and 178 read with Schedule IV to the Companies Act, 2013. A
structured questionnaire was prepared after taking into consideration inputs received from
the Directors, covering various aspects of the Board's functioning such as adequacy of the
composition of the Board and its Committees, execution and performance of specific duties
by the Board of Directors, independence governance, ethics and values, attendance and
contribution at meetings etc.
The performances of the Independent Directors were evaluated by the
Board after seeking inputs from all the directors on the effectiveness and contribution of
the Independent Directors.
The performance of the Committees was evaluated by the Board after
seeking inputs from the Committee members based on the criteria such as the composition of
Committees, effectiveness of Committee Meetings, etc.
The Board reviewed the performance of the individual directors on the
basis of criteria such as the contribution of the individual director to the Board and
Committee Meetings, like preparedness on the issues to be discussed, meaningful and
constructive contribution and inputs in Meetings, etc. In addition, the Chairman was also
evaluated on the key aspects of his role.
In a separate meeting of Independent Directors, performance of the
Non-Independent Directors, performance of the Board as a whole and performance of the
Chairman was evaluated, taking into account the views of Executive Directors and Non-
Executive Directors. The Independent Directors also assessed the quality, quantity and
timeliness of flow of information between the Board and the management that is necessary
for the Board to perform its functions reasonably and effectively. The same was discussed
in the Board Meeting that followed the meeting of the Independent Directors.
FINANCIAL STATEMENTS:
In accordance with the provisions of Section 129 (3) of the Companies
Act, 2013, the Standalone and Consolidated Financial Statements, drawn up in accordance
with the applicable Accounting Standards, form part of this Annual Report.
In accordance with Rule 8 (1) of Companies (Accounts) Rules 2014, the
highlights of performance of the Subsidiaries, Associates and Joint Ventures and their
contribution to the overall performance of the Company have been detailed in Annexure -
1 enclosed to this report.
Further, the annual accounts of all the subsidiary companies are
available on the Company's website www.vbshilpa.com
Annual accounts of the Subsidiary Companies and related detailed
information will be available for inspection by the members, at the registered office of
the Company and will also be made available to the members upon request.
ADEQUACY OF INTERNAL FINANCIAL CONTROLS WITH REFERENCE TO THE FINANCIAL
STATEMENTS:
The Company has Internal Control Systems, commensurate with the size,
scale and complexity of its operations. Various Audit systems in the Company monitor and
evaluate the efficacy and adequacy of the internal control systems of the Company, its
compliance with operating systems, accounting procedures and policies at all locations of
the Company. Based on the audit reports, the concerned department/ unit undertakes
corrective action in the respective areas and strengthens the controls. Significant audit
observations and corrective actions thereon are presented to the Audit Committee of the
Board periodically.
The Board of Directors of the Company have adopted various policies
like Related Party Transactions Policy, Whistle Blower Policy, Policy to determine
Material Subsidiaries, Code of Conduct for Regulating, Monitoring and Reporting Insider
Trading and such other procedures for ensuring orderly and efficient conduct of its
business for safeguarding its assets, prevention and detection of frauds and errors,
accuracy and completeness of the accounting records and timely preparation of reliable
financial information.
DETAILS OF THE COMPANIES WHICH HAVE BECOME OR CEASED TO BE
SUBSIDIARIES, JOINT VENTURES OR ASSOCIATE COMPANIES DURING THE YEAR UNDER REVIEW:
The following instances took place during the year under review which
need to be reported in accordance with Rule 8(5) (iv) of Companies (Accounts) Rules, 2014:
During the year, apart from Pilnova Pharma Inc, a subsidiary in USA
there are no new Companies that have become Subsidiaries/Joint ventures/ Associate
Companies of Shilpa Medicare Limited.
Your Company has filed a Second Stage petition with National Company
Law Tribunal for effecting the amalgamation with INM Technologies Private Limited being
the wholly owned subsidiary, The Company is awaiting for the final order of the Hon'ble
tribunal in this regard.
Your Company has filed a Second Stage petition with National Company
Law Tribunal for effecting the amalgamation with Shilpa Therapeutics Private Limited being
the wholly owned subsidiary, The Company is awaiting for the final order of the Hon'ble
tribunal in this regard.
DIRECTORS' RESPONSIBILITY STATEMENT:
Pursuant to Section 134 (5) of the Companies Act, 2013 Your Directors'
confirm that:
Applicable accounting standards have been followed in the preparation
of the annual accounts and that no material departures have been made from the same;
Accounting policies have been selected and applied consistently.
Judgments and estimates made are reasonable and prudent, so as to give a true and fair
view of the state of affairs of the Company at the end of the FY2023 and of the profit of
the Company for that period;
Proper and sufficient care has been taken to maintain adequate
accounting records in accordance with the provisions of the Act for safeguarding the
assets of the Company and for preventing and detecting fraud and other irregularities;
Annual accounts have been prepared on a going concern basis
Adequate internal financial controls for the Company to follow have
been laid down and these are operating effectively; and
Proper and adequate systems have been devised to ensure compliance with
the provisions of all applicable laws and these systems are operating effectively
EXTRACT OF ANNUAL RETURN:
In accordance with Section 92(3) of the Act and rule 12(1) of the
Companies (Management and Administration) Rules, 2014 (as amended), a copy of the Annual
Return of the Company has been placed on the Website of the Company at www.vbshilpa.com
OTHER DISCLOSURES:
Committees of Board:
Your Company has the following committees, namely: Audit Committee
Nomination and Remuneration Committee Stakeholders Relationship
Committee Corporate Social Responsibility Committee Risk Management Committee
The constitutions of all the committees are as per the provisions of
the Companies Act, 2013 and SEBI (LODR) Regulations, 2015. The details of the constitution
are mentioned in Corporate Governance Report, which forms part of this Annual Report.
CORPORATE GOVERNANCE REPORT:
Regulation 15 of SEBI (LODR) Regulations, 2015 is applicable to your
Company and as such the details as specified in Schedule V(C) of SEBI (LODR) Regulations,
2015, with regard to Corporate Governance Report including Practicing Company Secretary's
Certificate on compliance with the conditions of Corporate Governance specified in
Schedule V(E) of SEBI (LODR) Regulations, 2015 as well as a certificate as specified in
Schedule V(C) (10)(i) of SEBI (LODR) 2015 forms part of the Annual report as Annexure-
6.
MANAGEMENT DISCUSSION AND ANALYSIS:
The Management Discussion and Analysis Report for the year under review
as stipulated under Regulation 34 read with Schedule V (B) to the SEBI (LODR) Regulations,
2015 is annexed hereto and forms part of this Annual Report.
VIGIL MECHANISM:
In pursuance to the provisions of Section 177(9) & (10) of the
Companies Act, 2013 and Regulation 22 of SEBI (LODR) Regulations, 2015, a vigil mechanism
for directors and employees to report genuine concerns has been established. The Policy on
vigil mechanism i.e. Whistle Blower Policy may be accessed on the Company's website at
https://www.vbshilpa.com. The policy provides for a framework and process for safeguard
against victimization of director(s) or employee(s) or any other person who avail the
mechanism and allow direct access
to the Chairman of the Audit Committee in exceptional cases. Your
Company adheres to uncompromising integrity in conduct of its business and strictly abides
by well-accepted norms of ethical, lawful and moral conduct. It has zero tolerance for any
form of unethical conduct or behaviour. Directors and employees are at liberty to report
unethical practices.
REMUNERATION RATIO OF THE DIRECTORS/ KEY MANAGERIAL
PERSONNEL/EMPLOYEES:
Statement showing disclosures pertaining to remuneration and other
details as required under Section 197(12) of the Companies Act, 2013 read with Rule 5(1)
of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014 is
enclosed herewith as Annexure-7.
PARTICULARS OF EMPLOYEES:
Statement of employees as required under Rule 5(2) of the Companies
(Appointment and Remuneration of Managerial Personnel) Rules, 2014, is enclosed as Annexure
- 8 to the Board's Report.
COST RECORDS AND COST ACCOUNTS:
The Company is maintaining cost records and accounts as specified by
the Central Government under subsection (1) of section 148 of the Companies Act, 2013.
DISCLOSURE UNDER SEXUAL HARASSMENT OF WOMEN AT WORKPLACE (PREVENTION,
PROHIBITION, AND REDRESSAL) ACT, 2013:
Your Company has always provided a safe and harassment free workplace
to every individual working in its premises through various policies and practices. Your
Company always endeavors to create an environment that is free from discrimination and
harassment, including sexual harassment. Your Company has been actively involved in
ensuring that the clients and all the employees are aware of the provisions of the POSH
Act, 2013 and the rights available to them there under.
Your Company has in place an Anti-Sexual Harassment Policy in line with
the requirements of the Sexual Harassment of Women at workplace (Prevention, Prohibition
and Redressal) Act, 2013. Internal Complaints Committee has been set up to redress the
complaints received regarding sexual harassment. Your Company did not receive any
complaints during the period under review.
PARTICULARS OF LOANS, GUARANTEES OR INVESTMENTS:
Details of the loans granted, guarantees given, securities provided and
investments made during the year under review, as covered under Section 186 of the
Companies Act, 2013, are detailed in the notes to the financial statements which may be
read as a part of this Report.
DEPOSITS:
During the year under review, your Company has not accepted any
deposits within the meaning of Section 73 of the Companies Act, 2013 read with the
Companies (Acceptance of Deposits) Rules, 2014.
RELATED PARTY TRANSACTIONS:
Related Party Transactions entered into during the financial year under
review are disclosed in Note No. 45 to the Financial Statements. These transactions were
at an arm's length basis and in the ordinary course of business. There were no materially
significant Related Party Transactions with the Company's promoters, directors, management
or their relatives which could have had a potential conflict with the interests of the
Company. Form AOC-2, containing a note on the aforesaid Related Party Transactions is
enclosed herewith as Annexure - 9.
Related Party disclosures as per Schedule V of SEBI (LODR) Regulations,
2015 are enclosed herewith as Annexure - 10.
The policy on Related Party Transactions, as approved by the Board may
be accessed on the Company's website https://www.vbshilpa.com/pdf/related party
policy.pdf.
BUSINESS RESPONSIBILITY & SUSTAINABILITY REPORT:
The SEBI vide its circular dated 10 May 2021 made Business
Responsibility & Sustainability (BRSR) Mandatory for top 1000 Listed Companies (by
Market Capitalization) from the FY 2023, while disclosure was voluntary for the FY 2022.
Pursuant to Clause 34(2)(f) of the SEBI (LODR) Regulations, 2015
Business Responsibility & Sustainability Report, being applicable to the Company,
forms part of the Board Report as Annexure - 11.
GENERAL:
Your Directors state that no disclosure or reporting is required in
respect of the following items as there were no transactions on these items during the
year under review:
Issue of equity shares with differential rights as to dividend, voting
or otherwise. Issue of shares (including sweat equity shares) to employees of the Company
under any scheme.
Neither the Managing Director nor the Whole-time Director of the
Company received any remuneration or commission from any of its subsidiaries.
No significant or material orders were passed by the Regulators or
Courts or Tribunals which impact the going concern status and Company's operations in
future.
No frauds were reported by the auditors during the year under review.
There are no material changes and commitments affecting the financial
position of the Company occurred between the end of the financial year to which the
financial statements relate and the date of the report.
No applications were filed before or any proceedings pending under the
Insolvency and Bankruptcy Code, 2016
The details of Difference between valuation done at the time of one
time settlement and the valuation done while taking loan from the banks and financial
institutions along with the reason thereof - Not Applicable.
The Company has complied with Secretarial Standards, i.e. SS-1, and
SS-2 relating to Meetings of the Board of Directors and General Meetings respectively,
issued by the Institute of Company Secretaries of India and notified by the Ministry of
Corporate Affairs.
Your Directors wish to express their gratitude to the Central and State
Governments, investors, analysts, financial institutions, banks, business associates and
customers, the medical profession, distributors and suppliers for their whole- hearted
support. Further, Your Directors would like to express the appreciation to all the
employees of your Company for their continued dedication, significant contributions, hard
work and commitment towards achieving the objects of the Company.
For and on behalf of the Board of Directors |
Shilpa Medicare Limited |
|
Sd/- |
|
Omprakash Inani |
Place: Raichur |
Chairman |
Date: 8th August, 2024 |
DIN: 01301385 |