Shilpa Medicare Ltd has received Good Manufacturing Practice (GMP) certification from a European Union (EU) agency for its Unit 7 facility in Telangana.
The certification followed a successful inspection by the European Medicines Agency, Austria, held from September 24 to September 26 at the Nacharam, Hyderabad facility. Unit 7 has Analytical Services Division, (QC), and the Bio-Analytical
Department that play the major role in testing of drug substances, raw materials, packaging materials, and finished products. This is the first inspection by any European agency for the QC laboratory of Unit 7. For the company, this will be a significant milestone.
In the National Stock Exchange, shares of Shilpa Medicare Ltd is currently trading at ₹772.40 at 1:20 pm on December 23, 2024. This is a 5% dip than the previous close.
The facility also carries out analytical method validations, method transfers, and other special analytical studies. These samples, coming to this laboratory, are meant for the final release to key markets in the United States, European Union, and so on.
Both the Analytical Services and Bio-Analytical Laboratories at Unit 7 have already received approval from the USFDA.
Furthermore, the Bio-Analytical Laboratory is certified by EMA Europe, establishing Shilpa Medicare as compliant with international standards. This achievement further enhances the capabilities of the company in satisfying global pharmaceutical regulatory requirements and expands its reach in the US and EU markets.
