This audit at the Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, was a Pre-Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs) for oncology and non-oncology products, a press release said.
Published Date – 13 April 2024, 04:27 PM
This audit at the Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, was a Pre-Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs) for oncology and non-oncology products, a press release said.
Hyderabad: Granules India Limited has announced that the company’s Unit V facility has successfully completed the US Food and Drug Administration (FDA) inspection between April 8 and 12, resulting in zero 483 observations.
This audit at the Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, was a Pre-Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs) for oncology and non-oncology products, a press release said.
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, said, “We are very proud to reiterate that our focus on high-quality standards is comparable to the best global benchmarks as we receive zero observations from US FDA audits.”
Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service.
