USFDA closes inspection at Shilpa Medicare Hyderabad lab
Karnataka: Shilpa Medicare has announced that the United States Food and Drug Administration (USFDA) has closed the inspection at the Company's Bio Analytical Laboratory in Hyderabad without any 483 observation.
The Laboratory was inspected from 26 Feb, 2024 to 01 March, 2024.
"This is to inform you that Bio Analytical Laboratory, Shilpa Medicare Limited, Unit 7, Nacharam, Hyderabad, India was inspected by USFDA from 26 Feb, 2024 to 01 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 has informed in a BSE filing.
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently and this is the first USFDA inspection.
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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.
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Shilpa Medicare Limited started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of API and Formulation globally in different regulated markets.
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