The inspection was conducted from 24 September 2024 to 26 September 2024. On conclusion of the inspection the company has received the Good Manufacturing Practice (GMP) Certification.
Unit VII of Shilpa Medicare houses an Analytical Services Division (QC) and a Bio-Analytical Department, both of which are approved by the USFDA. Notably, the Bio-Analytical Laboratory is already approved by EMA, Europe.
This inspection was the first Europe inspection for the QC laboratory of Unit VII. This Laboratory is involved in testing drug substances, raw materials, packing materials and finished products. It is also engaged in other analytical activities like analytical method validations, method transfers and other miscellaneous analytical studies. The laboratory has been testing samples for final release into US, EU and other markets.
Raichur-based Shilpa Medicare is a vertically integrated manufacturer and distributor of quality drugs to global markets, specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.
The company’s consolidated net profit soared to Rs 17.94 crore in Q2 FY25 as against Rs 1.61 crore posted in Q2 FY24. Revenue from operations rose 9.8% to Rs 343.80 crore in the quarter ended 30 September 2024.
The scrip shed 0.03% to Rs 828.75 on the BSE.