Hyderabad-based contract research organisation GVK Biosciences (GVK Bio) on Monday said that its Ahmedabad clinical pharmacology unit had cleared the US Food and Drug Administration (USFDA) audit.
The US drug regulatory has visited and audited the Ahmedabad unit, which was commissioned in 2010. The unit has three clinics with 110 beds and has the capability to execute some human patient-based studies.
The Ahmedabad facility carries out bio-availability and bio-equivalence (BA/BE) studies that are submitted to various regulatory agencies including FDA, TGA (Australia), European regulatory agencies, Health Canada, ANVISA-Brazil and ministry of health (MoH), Turkey. The unit has also been inspected and approved by three other regulators including Drugs Controller General of India (DCGI), ANVISA-Brazil and MoH, Turkey.
“Both our Ahmedabad and Hyderabad units are ready and the sponsor can carry out studies from both the places,” Manni Kantipudi, CEO, GVK BIO, said in a press release.
GVK Bio’s clinical pharmacology unit, which was formed in 2003, has so far completed more than 750 studies.