Granules India Limited has announced that its Unit V facility located in Visakhapatnam has passed an inspection by the US Food and Drug Administration (FDA) with zero observations (commonly referred to as 483 observations).

The inspection, conducted between April 8 and 12, 2024, was specifically a Pre-Approval Inspection (PAI) and cGMP audit focusing on Active Pharmaceutical Ingredients (APIs) and formulations of both oncology and non-oncology products.

Granules India is a renowned pharmaceutical company with a diverse product portfolio that includes APIs, Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). Its products are distributed across more than 80 countries worldwide.

The company operates 10 manufacturing facilities, with two located in the USA and eight in India.

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, expressed pride in the company's ability to maintain exceptionally high-quality standards, comparable to global benchmarks, as evidenced by the flawless outcome of the US FDA audit. Dr. Chigurupati reaffirmed Granules India's commitment to manufacturing products that contribute to enhancing healthcare standards globally.

The successful clearance of the US FDA inspection underscores Granules India's dedication to ensuring compliance with regulatory standards and delivering safe and effective pharmaceutical products to consumers worldwide.