Dr Reddy's Laboratories Ltd (DRL) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services &Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including Active Pharmaceutical Ingredients (APIs), custom pharmaceutical services, generics, biosimilars and differentiated formulations. The company's major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe. Its major markets include - USA, India, Russia & CIS countries, and Europe.
Dr Reddy's Laboratories was incorporated in the year 1984 in Hyderabad. The company was established by Dr Anji Reddy with an initial capital outlay of Rs 25 lakh. The company made their beginning with the manufacture of Active Pharmaceutical Ingredients and Intermediates (API) and commenced operations with a single drug in a 60-tonne facility near Hyderabad, India. In the year 1986, the company shares were listed on the Bombay Stock Exchange. Also, they entered international market with exports of Methyldopa.
In the year 1987, the company obtained first USFDA approval for Ibuprofen API. In the year 1988, they acquired Benzex Laboratories Pvt Ltd to expand their Bulk Actives business. In the year 1990, they exported Norfloxacin and Ciprofloxacin to Europe and Far East. In the year 1991, they commenced formulation exports to Russia.
In the year 1993, the company established Dr. Reddy's Research Foundation and initiated drug discovery programme. In the year 1994, they finished dosages facility established to cater to highly regulated markets such as the US. In the year 1995, the company set up joint venture in Russia. In the year 1997, they filled first ANDA with the United States Food and Drug Administration for Ranitidine.
In the year 1999, the company acquired American Remedies Ltd, a pharmaceutical company based in India. In the year 2000, Cheminor Drugs Ltd, a group company merged with the company and thus the company became India's third largest pharma company. In the year 2001, the company launched Fluoxetine capsules. They became the first Indian company to win 180-day exclusivity for a generic drug in the US. Also, they launched their first generic product, Ranitidine, in the US market.
In the year 2002, the company made their first overseas acquisition of BMS Laboratories Limited and Meridian Healthcare in UK. In the year 2003, they launched Ibuprofen, first generic product to be marketed under the 'Dr. Reddy's' label in the US. In the year 2005, they acquired Roche's API Business at its manufacturing site in Mexico.
In the year 2006, the company acquired Betapharm the fourth largest generics company in Germany for a total enterprise value of Rs 480 million. In the year 2007, the company launched Reditux - the world's first biosimilar MAb - for the treatment of Non Hodgkins Lymphoma. Also, they became India's leading and most profitable pharmaceutical company.
During the year 2008-09, the company acquired DowPharma's small molecules business in UK under Chirotech Technology Ltd, BASF Corporation's manufacturing facility at Shreveport in Louisiana, USA under Dr. Reddy's Laboratories Louisiana LLC and Jet Generici SRL, a company engaged in the sale of generic finished dosages in Italy. In addition, Perlecan Pharma Pvt Ltd, Macred India Pvt Ltd and Dr. Reddy's Laboratories ILAC Ticaret also became subsidiary of the company.
During the year 2009-10, Dr. Reddy's Pharma SEZ Ltd was incorporated as a wholly-owned subsidiary of the company for the purpose of formulation manufacturing at Special Economic Zone and Perlecan Pharma Pvt Ltd was amalgamated with the company. Further, the company acquired the balance stake of 30% in Dr. Reddy's (Australia) Pty Ltd. The company filed 12 Abbreviated New Drug Applications (ANDAs) in US including six Para IV filing during the year.
During the year 2010-11, the company acquired GlaxoSmithKline's (GSK) oral penicillin manufacturing facility located in Tennessee, USA. This allows the company to enter theUS penicillin-containing antibacterial market segment through brands such as Augmentin and Amoxil, and serve the needs of customers through manufacturing and other capabilities that did not previously exist within the company. Also, they increased the stake in the South African joint venture company to 100% after acquiring the 40% stake of the partner.
During the year, the company launched Cresp in India, the first biosimilar darbepoetin alfa in the world. In March 2011, they launched Peg-grafeelTM in India in the form of an affordable pegfilgrastim, which is used to stimulate the bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. Peg-grafeelTM
During the year, Idea2Enterprises (India) Pvt Ltd, Dr. Reddy's Laboratories Romania SRL, I-Ven Pharma Capital Ltd, Dr. Reddy's Laboratories Tennessee LLC and Dr. Reddy's Venezuela C.A. became wholly-owned subsidiaries of the company. Further, Dr. Reddy's Laboratories (Proprietary) Ltd also became wholly-owned subsidiary by virtue of purchase of its balance 40% stake by the company. Also, Macred India Pvt Ltd ceased to be a subsidiary of the company.On 27 July 2012, Dr. Reddy's Laboratories announced that the United States Food and Drug Administration (USFDA) had lifted import alert on its chemical manufacturing facility at Cuernavaca, Mexico after inspection of the unit in March 2012. Earlier, Dr. Reddy's Mexico facility was inspected by USFDA in November 2010 and based on observations by the USFDA, a warning letter was issued to the company on 14 June 2011.On 8 October 2012, the Custom Pharmaceutical Services (CPS) business of Dr. Reddy's Laboratories Ltd. announced expansion in the areas of activated mPEG manufacturing and in the development and manufacture of NCE (New Chemical Entities) APIs for use in pre-clinical through to commercial development at its manufacturing facility in Mirfield, UK.On 14 December 2012, Dr. Reddy's Laboratories announced that it had launched the recommended public offer to acquire all the issued and outstanding shares of OctoPlus N.V., a service based specialty pharmaceutical company, at an offer price of EUR 0.52 (cum dividend) per share. Shareholders (including certain members of the Boards) holding in aggregate 63.5% of the issued and outstanding ordinary shares of OctoPlus entered into irrevocable undertakings to tender their shares under the offer. On 28 February 2013, Dr. Reddy's Laboratories announced that it had raised its stake in OctoPlus N.V, to 98.6% following a public offer for all the issued and outstanding ordinary shares in the capital of OctoPlus. OctoPlus is a leading European provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult-to formulate active pharmaceutical ingredients.On 19 December 2014, Dr. Reddy's Laboratories announced that it had completed the acquisition of Habitrol brand (an over-the-counter nicotine replacement therapy transdermal patch) from Novartis Consumer Health Inc. following issuance of the proposed consent order from the US Federal Trade Commission (FTC) on 26 November 2014. The company had earlier entered into an asset purchase agreement with Novartis Consumer Health Inc. to acquire the title and rights of Habitrol brand and to market the product in the US market.On 22 March 2015, Dr. Reddy's Laboratories (NYSE: RDY) announced that it had settled its claims against Nordion Inc. (formerly MDS Inc.), headquartered in Ottawa, Canada, in a case pending in the United States District Court for the District of New Jersey, for a cash payment of USD 22.5 Million by Nordion to Dr. Reddy's. The case was brought by Dr. Reddy's in April 2009 seeking damages sustained by the company caused by a claimed breach by Nordion of its Laboratory Services Agreement with Dr. Reddy's. Nordion, as a contract research organization, provided laboratory services to Dr. Reddy's, including bio-equivalency studies, to support Dr. Reddy's regulatory applications for approval of generic drugs, including Abbreviated New Drug Applications (ANDAs) filed with the United States Food and Drug Administration (the USFDA) for approval to market generic drugs in the United States. The case arose after the USFDA cited MDS with violations of good laboratory practices which caused the USFDA not to accept, without further substantiation, MDS's laboratory reports performed during the period 2000-2004.
On 23 March 2015, Dr Reddy's Laboratories announced that it has entered into an agreement with Hetero, under which Dr. Reddy's has been licensed to distribute and market Sofosbuvir 400 mg tablets , indicated in the treatment of Chronic Hepatitis C, under the brand name Resof, in India.
On 1 April 2015, Dr. Reddy's Laboratories announced that it has entered into a definitive agreement to acquire a select portfolio of the established products business of UCB, a global biopharmaceutical company, in the territories of India, Nepal, Sri Lanka and Maldives. The revenue of the acquired business stood at approximately Rs 150 crore for calendar year 2014.On 29 May 2015, Dr Reddy's Laboratories Limited and AstraZeneca Pharma India Limited entered into a distribution agreement for saxagliptin and its fixed dose combination with metformin, in Type 2 DiabetesOn 6 August 2015, Dr. Reddy's Laboratories Ltd. announced that it has entered into a strategic collaboration with Amgen, one of the world's leading independent biotechnology companies, to market and distribute three Amgen medicines in India in the areas of oncology and cardiology. On 16 September 2016, Dr. Reddy's announced that it had expanded its strategic collaboration with Amgen to market and distribute three of Amgen's medicines in India in the therapy areas of oncology and osteoporosis.
On 9 September 2015, PanTheryx Inc., a global medical nutrition company based in Boulder, Colorado, and Dr. Reddy's Laboratories Ltd. announced a multi-country supply and licensing agreement whereby Dr. Reddy's Lab got the exclusive right to market and distribute PanTheryx's breakthrough nutritional intervention, DiaResQ, for infectious diarrhea in India and Nepal and in process for Russia, Myanmar, Vietnam, Ukraine, Sri Lanka, Kazakhstan, Belarus, Jamaica, and select LATAM markets. Dr. Reddy's will market the product in India and Nepal under the Reliqua brand.
On 14 September 2015, Dr. Reddy's Laboratories announced the signing of a commercialization deal with Hatchtech, an Australian pharmaceutical company developing an innovative prescription head lice product, Xeglyze Lotion. The exclusive rights for this product are applicable for the territories of the United States, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela.
On 4 November 2015, Dr. Reddy's Laboratories entered into a strategic alliance with Biocodex, a multinational pharmaceutical company, to market and distribute Biocodex products in the Romanian market.
On 5 November 2015, the US Food and Drug Administration (USFDA) issued a warning letter to Dr. Reddy's Laboratories relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. This action follows the earlier inspections of these sites by the agency in November 2014, January 2015 and February 2015 respectively.
On 18 November 2015, Dr. Reddy's Laboratories announced that it had completed the purchase of worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug from its Australian partner, Alchemia Limited. Earlier, the company had signed a term sheet for this transaction in September 2015. Fondaparinux is a generic version of the anticoagulant drug Arixtra.
On 11 March 2016, Dr. Reddy's Laboratories Ltd. and TR-Pharm announced a strategic collaboration agreement for the manufacture and commercialization of a portfolio of Dr. Reddy's Laboratories' biosimilar drugs in Turkey.
On 28 March 2016, Dr. Reddy's Laboratories and XenoPort, Inc. announced that they have entered into a license agreement pursuant to which Dr. Reddy's Laboratories will be granted exclusive US rights for the development and commercialization of XenoPort's clinical stage oral new chemical entity, XP23829. Dr. Reddy's Laboratories plans to develop XP23829 as a potential treatment for moderate-to-severe chronic plaque psoriasis and may potentially develop XP23829 for relapsing forms of multiple sclerosis (MS).
On 31 March 2016, Dr. Reddy's Laboratories announced that it has entered into a licensing agreement with Eisai Co., Ltd, Japan by which Dr. Reddy's will be granted exclusive worldwide development and commercialization rights (excluding Japan and Asia) for Eisai's investigational anticancer agent E7777. Eisai will be responsible for the development and marketing of E7777 in Japan and Asia, while Dr. Reddy's holds the option for rights to develop and market the agent in India.
On 25 May 2016, Dr. Reddy's Laboratories announced the acquisition of an eminent portfolio of over-the-counter (OTC) brands in the US in the cough-and-cold, pain, and dermatology categories from Ducere Pharma.
On 3 August 2016, Dr. Reddy's Laboratories announced that it successfully completed the previously announced acquisition of a portfolio of complex generic products in the US from Teva Pharmaceutical Industries Ltd. and an affiliate of Allergan plc. On 11 June 2016, Dr. Reddy's Laboratories entered into a definitive agreement with Teva Pharmaceutical Industries Ltd. and an affiliate of Allergan plc to acquire a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the US for $350 million in cash.
On 7 October 2016, Dr. Reddy's Laboratories announced its entry into Colombia with its portfolio of high quality and affordable medicines for Cancer patients.
On 26 October 2016, Dr. Reddy's Laboratories announced that it had entered into a strategic collaboration with Gland Pharma, a globally recognized developer and manufacturer of sterile dosage forms, to market and distribute a diverse portfolio of eight injectable Abbreviated New Drug Applications (ANDAs) in the United States.
On 8 February 2017, Dr. Reddy's Laboratories Ltd announced the expansion of its commercial operations in Europe with the introduction of its portfolio of generics in France.
On 3 March 2017, Dr. Reddy's Laboratories announced that it had completed the acquisition of 100% stake in Imperial Credit Private Limited, a Non-Banking Finance Company (NBFC), based out of Kolkata, for a consideration of Rs 2.05 crore. The company proposes to undertake the group's captive financial activities through this entity.
On 27 March 2017, Dr. Reddy's Laboratories and Integra LifeSciences Holdings Corporation, a leading global medical technology company, announced that they have entered into an exclusive distribution agreement. Under the agreement, Dr. Reddy's will market and distribute DuraGen Plus and Suturable DuraGen Dural Regeneration Matrices for use in patients in India. The DuraGen product line offers Duraplasty Solutions meant for the repair of the dura mater. Dura mater is a thick membrane that surrounds the brain and spinal cord, and contains the cerebrospinal fluid (CSF). DuraGen Plus Dural Regeneration Matrix is indicated as a dural substitute for the repair of dura mater.
On 27 July 2017, Dr Reddy's Laboratories Ltd. and CHD Bioscience Inc., a privately-held biopharmaceutical company, announced a global licensing agreement for the clinical development and commercialization of Dr. Reddy's phase III clinical trial candidate, DFA-02. It is intended to be used for the prevention of surgical site infections, following non-emergency, elective colorectal surgery. Under the terms of the agreement, Dr. Reddy's would receive equity in CHD valued at $30 million upon an IPO of CHD or a minimum of $30 million in cash within 18 months of execution of the agreement. Dr. Reddy's will also receive additional milestone payments of $40 million upon USFDA approval. In addition, CHD will pay Dr. Reddy's double-digit royalties on sales and commercial milestones.
On 22 August 2017, Dr. Reddy's Laboratories Ltd. through its wholly owned subsidiary Promius Pharma, LLC, announced that it has out-licensed the future development, manufacturing, and commercialization rights of DFD-06, a topical high potency steroid, to Encore Dermatology Inc. The drug is intended to be used for treatment of moderate to severe plaque psoriasis. Under the terms of the agreement, Encore will be responsible for the commercialization of DFD-06 in the United States. Promius Pharma is eligible to receive certain pre- and post- commercialization milestone payments of up to USD $32.5 million, followed by fixed royalty payments on net sales.
On 19 December 2017, Dr. Reddy's Laboratories Ltd. announced that its US subsidiary had reached a settlement with the US Government in a case involving packaging for five blister-packed prescription products. In a joint filing by the parties, Dr. Reddy's and the US Department of Justice agreed to the settlement of the action without any adjudication of any issue of fact or law.
In FY2018, the company filed 19 new Abbreviated New Drug Applications (ANDAs) and one New Drug Application (NDA) with the USFDA.
As of 31 March 2018, the company had 110 generic filings pending approval from the USFDA, comprising 107 ANDAs and three NDAs filed under the 505(b)(2) route of the US Federal Food, Drug and Cosmetic Act. Of the 107 ANDAs, 63 are Para IV applications.
The company had 51 subsidiaries and two joint venture companies as on 31 March 2018. During FY2018, Dr. Reddy's Laboratories Chile SpA. (in Chile), Dr. Reddy's (WUXI) Pharmaceutical Co. Limited (in China), Dr. Reddy's Laboratories Malaysia Sdn. Bhd. (in Malaysia) and Dr. Reddy's Laboratories Taiwan Limited (in Taiwan) have become subsidiary companies. DRSS Solar Power Private Limited was closed and ceased to be a joint venture company.
In FY2019, the company filed 20 new Abbreviated New Drug Applications (ANDAs) with the USFDA. As on 31 March 2019, the company had 110 generic filings pending approval from the USFDA - comprising 107 ANDAs and three New Drug Applications (NDAs).
The company had 52 subsidiaries and two joint venture companies as on 31 March 2019. During FY2019, Dr. Reddy's Laboratories (Thailand) Limited and Dr. Reddy's Laboratories Philippines Inc. have become subsidiary companies. Pursuant to sale of all the issued and outstanding membership interests in the antibiotic manufacturing facility at Tennessee, USA, Dr. Reddy's Laboratories Tennessee, LLC ceased to be a subsidiary.
During FY2019, the company launched 15 new brands in India. The company spent towards R&D expenses during FY2019 for the amount of Rs 15,607 million, or 10.1% of revenue, versus 12.9% in FY2018.
The company had 50 subsidiaries and two joint venture companies as on 31 March 2020. During FY2020, Aurigene Pharmaceutical Services Limited was incorporated as a step-down subsidiary company. Dr. Reddy's Singapore Pte. Limited and Reddy Antilles N.V. were closed and ceased to be wholly-owned subsidiaries. Dr. Reddy's Laboratories International SA ceased to be a step-down subsidiary of the company consequent to its merger with Dr. Reddy's Laboratories SA.
During FY2020, the company launched 21 new brands in India. The company also entered the nutrition segment with the launch of our diabetes nutrition drink Celevida'. The company spent towards R&D expenses during FY2020 amounting to Rs 15,410 million, or 8.8% of revenue, versus 10.1% in FY2019.
On 10 June 2020, the company completed the acquisition of select divisions of Wockhardt Limited's branded generics business in India and the territories of Nepal, Sri Lanka, Bhutan and Maldives. The business comprises a portfolio of 62 brands in multiple therapy areas, such as respiratory, neurology, venous malformations, dennatology, gastroenterology, pain, and vaccines. This entire portfolio has been transferred to the Company, along with related sales and marketing teams, the manufacturing plant located in Baddi, Himachal Pradesh, and employees. During the quarter ended 30 September 2020, the company completed the purchase price allocation. The fair value of consideration transferred is Rs 16,115 million. The company recognised Rs 373 million, Rs 14,888 million and Rs 530 million towards property, plant and equipment, intangible assets, and goodwill, respectively. The acquisition pertains to Company's Global Generics segment.
On 22 October 2020, the Company experienced a cybersecurity incident related to ransomware. The Company could contain the incident in a timely fashion and has also ensured that all traces of the infection are completely cleaned from the network. All affected systems were restored and brought back to normalcy in the order of priority. Based on the forensic investigation, no evidence was found of any data breaches leading to personally identifiable information. Since then, the Company has also been focused on implementing significant improvements to its cyber and data security systems to safeguard from such risks in the future.
The Company continues to consider the impact of COVID-19 pandemic in assessing the recoverability of receivables, goodwill, intangible assets, and certain investments.
During December 2020, the company entered into a definitive agreement with Glenmark Phannaceuticals Ltd. to acquire, certain brands in various Emerging Market countries for a total consideration of Rs 1,516 million. The said transaction was accounted for as an acquisition of product related intangibles.
In FY 2020, Company filed 8 new Abbreviated New Drug Applications (ANDAs) with the USFDA. As on 31 March 2020, there were 99
generic filings pending approval from the USFDA, comprising 97 ANDAs and 2 New Drug Applications (NDAs).
During the year, the Company filed 20 abbreviated new drug applications (ANDAs) and 1 new drug application (NDA) in the USA. As of March 31, 2021, there were 95 generic filings awaiting approval with the US Food and Drug Administration (USFDA), comprising 92 ANDAs and 3 NDAs.
The company had 52 subsidiaries and 1 joint venture company as on March 31, 2021.
During FY 2021, Dr. Reddy's (Beijing) Pharmaceutical Company Limited in China and Dr. Reddy's Formulations Limited in India were incorporated as a step-down subsidiary company and a wholly-owned subsidiary, respectively. Pursuant to sale of the membership interests in DRANU, LLC, it ceased to be a joint venture during the year. Further, the company sold its Contract Development and Manufacturing Organization (CDMO) division of Custom Pharmaceutical Services (CPS) business to Aurigene Pharmaceutical Services Limited (APSL), a wholly-owned subsidiary, on slump sale basis, for a consideration of Rs. 5,434.5 million.
During year 2022, Company filed 7 Abbreviated New Drug Applications (ANDAs) in the USA. As of March 31, 2022, there were 90 generic filings awaiting approval with the US Food and Drug Administration (USFDA), comprising 87 ANDAs and 3 NDAs.
The Hon'ble National Company Law Tribunal (NCLT), Hyderabad Bench, vide order dated April 5, 2022, has approved the Scheme of Amalgamation and Arrangement for the merger of Dr. Reddy's Holdings Limited (the DRHL/ Amalgamating Company) with the Company, filed by both companies with the Registrar of Companies, Hyderabad, on April 8, 2022. Therefore, the merger became effective on April 8, 2022 with Appointed date of the Scheme, April 1, 2019.
The Company has 42 overseas subsidiary companies (including step-down subsidiaries), 9 subsidiary companies in India and 1 joint venture Company as on March 31, 2022.
Dr. Reddy's (WUXI) Pharmaceutical Co. Limited in China ceased to be a step-down subsidiary of the Company with effect from December 13, 2021, consequent to its liquidation. Aurigene Discovery Technologies Inc. in USA, ceased to be a step-down subsidiary of the Company with effect from March 23, 2022, consequent to its liquidation. Further, the Company acquired Nimbus Health GmbH (Nimbus) as a step-down subsidiary, on February 24, 2022.
During the year 2022-23, Dr. Reddy's Holdings Limited (the DRHL/ Amalgamating Company) got merged with Dr Reddy's Laboratories Ltd. (the Amalgamated Company) through the Scheme of Amalgamation and hence, the merger became effective on April 8, 2022.
Consequent to the merger with Dr. Reddy's Laboratories LLC, Russia, DRS LLC in Russia ceased to be a step down subsidiary of the Company with effect from July 1, 2022. Dr. Reddy's Laboratories B.V. in Netherlands, has ceased to be a step-down subsidiary of the Company with effect from January 25, 2023.
During the year 2023, the Company launched the generic version of Lenalidomide Capsules, a cancer drug used to treat myeloma in the United States; launched Sorafenib tablets, a drug used to treat a type of liver cancer called hepatocellular carcinoma; launched Timolol gel, an ophthalmic gel forming solution used to treat glaucoma.