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Granules India’s Unit V facility in Visakhapatnam completes US FDA inspection with Zero 483 Observations 

The facility manufactures APIs & formulations of oncology and non-oncology products 

Granules India announced that the Company’s Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, has 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. 

Dr Krishna Prasad Chigurupati, CMD, Granules India, “We are 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.”


 

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