Shilpa Pharma Lifesciences clears Brazilian GMP test with minor observations

Drug firm Shilpa Medicare Limited on Friday (July 4) announced that its wholly-owned subsidiary, Shilpa Pharma Lifesciences Limited, Unit-1, has successfully completed a Good Manufacturing Practice (GMP) inspection conducted by the Brazilian regulatory authority, ANVISA.The audit was held from June 30 to July 4, 2025, and concluded with no critical or major observations. A few procedural observations and recommendations were discussed during the inspection.
The company stated that it is committed to submitting an appropriate Corrective and Preventive Action (CAPA) plan addressing the procedural points within the stipulated timelines.
Also Read: Shilpa Medicare’s Raichur unit clears 2nd consecutive USFDA inspection with no observationsIn May this year, Shilpa Medicare said it had received the GMP certification from the European Union (EU) regulator for its manufacturing facility in Bengaluru.

The company said that it has been awarded the GMP certification by the European Medicines Agency (EMA) following the successful closure of an inspection at Unit VI located in Dabaspet in Bengaluru.The inspection was conducted by the Finnish Medicines Agency on behalf of EMA from March 10-14 and it concluded with a few minor observations, Shilpa Medicare said.

The GMP approval awarded to the pharmaceutical company’s facility is for the manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms being produced from this unit.

Also Read: Shilpa Medicare arm gets European Certificate Of Suitability for diarrhoea molecule

The two complex dosage forms being produced at Unit VI, Dabaspet, are oral mouth dissolving films and transdermal systems. The unit is already approved by the MHRA, UK, and the TGA, Australia.

Shares of Shilpa Medicare Ltd ended at ₹901.90, up by ₹14.15, or 1.59%, on the BSE.