USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad

This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently

The Bio Analytical Laboratory, Shilpa Medicare Limited, Unit 7, Nacharam, Hyderabad, India was inspected by USFDA from Feb 26, 2024 to March 1, 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.

This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently and this is the first USFDA inspection.

This 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.