GVK Bio Passes FDA Audit

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 Bioequivalence (BA/BE) studies that are submitted to various regulatory agencies including FDA, TGA (Australia), European Regulatory agencies, Health Canada, ANVISA-Brazil and MoH (Turkey).

Manni Kantipudi, chief executive officer, GVK Bio, said, “This is a clear testament to the high standards of quality and processes followed at GVK Bio. The sponsor can now carry out BA/BE studies at either of our sites, Ahmedabad or Hyderabad, with a wider choice of population and capacities.” The Ahmedabad clinical facility has the capability to conduct BA/BE studies in healthy human volunteers, in special populations and some patient-based studies.

The Ahmedabad success comes on the heels of regulatory joint inspection by FDA, ANSM (France), AGES (Austria) and WHO, of GVK’s Hyderabad facility. This inspection was the first joint inspection of a CRO by the four agencies. GVK Bio received no 483s by FDA in that inspection.