USFDA concludes inspection at Shilpa Medicare Hyderabad unit with zero observations
Karnataka: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has concluded the inspection at the Company's Bio Analytical Laboratory, Unit 7, Nacharam, Hyderabad, India with zero 483 observations and no discussion items.
The inspection was held from 26th February to 1st March 2024.
The Agency has concluded that this inspection has now been closed with the issuance of the Establishment Inspection Report (EIR). The facility is classified as “No Action Indicated” (NAI).
NAI means no objectionable conditions or practices were found during the inspection.
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies and BA/BE studies in human subjects as per global regulatory requirements. This is a newly set up Centre for bio-analytical testing and this is the first regulatory inspection and approval for this Site from USFDA. This facility is approved by EMA, Europe.
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Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the Oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.
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