FDA completes Granules audit

Hyderabad: The US Food and Drug Administration (USFDA) has completed an audit of Granules Pharmaceuticals Inc (GPI), in Chantilly, Virginia, wholly owned subsidiary of Hyderabad-based Granules India Limited, according to a company media release here.

This facility was inspected by the USFDA from June 21 to June 25. The audit is a pre-approval inspection for three products filed from this facility. "We will be responding to the two observations within the stipulated time period," said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc.

GPI is a US FDA & DEA approved facility which spreads over 100,000 sq ft area, with established R&D & Manufacturing capabilities for low volume, oral solid dosage forms.