USFDA concludes inspection at Shilpa Medicare’s Bio Analytical Laboratory

01 Mar 2024 Evaluate

The U.S Food and Drug Administration (USFDA) has concluded inspection at Shilpa Medicare’s Bio Analytical Laboratory, Unit 7, Nacharam, Hyderabad from February 26, 2024 to March 1, 2024. This 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.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.


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