The USFDA has conducted an inspection at the bio analytical laboratory of Shilpa Medicare, Unit 7, Nacharam in Hyderabad from 26 February 2024 to 1 March 2024.

This unannounced USFDA inspection has been closed without any 483 observation, stating the satisfactory compliance towards facility, systems and acceptability of data generated from this laboratory, the company stated in the press release.

The firm added that this newly set up centre for bio-analytical testing has already received European Regulatory Authority clearance recently and this is the first USFDA inspection.

The said unit of Shilpa Medicare is engaged in testing of biological samples that supports all exploratory pharmacokinetic studies, bioavailability studies and bioequivalence studies, while complying with good clinical practices and good laboratory practices as per the global regulatory standards.

Shilpa Medicare is a global brand in manufacturing and supplying of API and formulation globally in different regulated markets.

The company’s consolidated net profit stood at Rs 4.58 crore in Q3 FY24 as compared with net loss of Rs 6.62 crore posted in Q3 FY23. Net sales stood at Rs 286.48 crore in Q3 FY24, up 9.1% year on year.