The United States FDA has given the green light to GVK Bioscience, a contract research organisation’s Ahmedabad unit to carry out bioavailability and bioequivalence studies. The GVK BIO Ahmedabad facility, commissioned in 2010, has three clinics with 110 beds. The facility has already been inspected and approved by Drugs Controller General of India (DCGI), ANVISA-Brazil and the Turkish health ministry, the Hyderabad-based firm said in a statement here.
The Ahmedabad facility carries out bio-availability and bio-equivalence (BA/BE) studies that are submitted to various regulatory agencies including US Food and Drug Administration (USFDA), TGA (Australia), European regulatory agencies, Health Canada, ANVISA-Brazil and Turkey’s health ministry. ”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,” said Manni Kantipudi, CEO, GVK BIO. The GVK BIO Hyderabad facility is a full service provider of BA/BE services with four clinics and 144 beds supported by a bio-analytical facility.