Granules India Ltd. has announced that the company’s Unit V facility located at Anakapally, Visakhapatnam, Andhra Pradesh, India has completed the US Food and Drug Administration (FDA) inspection between April 8-12, 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.”

Amongst the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs), Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK.

The company has 10 manufacturing facilities out of which 8 are located in India and 2 are in the USA.