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No 483s at Clinical Pharmacology Unit
July 31, 2012
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
GVK Biosciences’ Clinical Pharmacology Unit in Ahmedabad successfully cleared an FDA audit with no 483s or observations. The agency visited and audited a First-to-File study for one of GVK Bio’s customers. The GVK Bio Ahmedabad facility, commissioned in 2010, has three clinics with 110 beds. The facility has been inspected and approved by Drugs Controller General of India (DCGI), ANVISA-Brazil and Ministry of Health (MoH)-Turkey. The Ahmedabad facility carries out Bioavailability and Bioe...
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