Granules India’s Unit V facility receives zero observations in FDA inspection

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.

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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.