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 wi...

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