Granules India’s Unit V facility in Visakhapatnam Successfully Completes US FDA Inspection with Zero 483 Observations

Granules India’s Unit V facility in Visakhapatnam Successfully Completes US FDA Inspection with Zero 483 Observations

Granules I

Hyderabad, 15th April 2024 Granules India Limited, announced that the Company’s Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, India has successfully completed the US Food and Drug Administration (FDA) inspection between 8th and 12th April 2024, resulting in zero 483 observations.

This audit was a Pre-Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs) for oncology and non-oncology products.

According to Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, “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. We will continue to move ahead and manufacture products that will enhance health care.”

Rabindra

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