Granules India completes US FDA audits at Visakhapatnam and Jeedimedtla facilities
The Vizag facility was inspected by the US FDA from June 26 to June 30, 2023 and the Jeedimetla facility from June 19 to June 23, 2023
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Hyderabad: Granules India Limited, a pharmaceutical company, has completed the U.S. Food and Drug Administration’s (US FDA) Pre-Approval Inspection (PAI) and GMP audit for their Unit IV facility at Visakhapatnam with zero 483 observations.
The pharmaceutical company's Jeedimetla facility in Hyderabad also successfully completed the US FDA’s surveillance inspection with zero 483 observations.
The Vizag facility was inspected by the US FDA from June 26 to June 30, 2023 and the Jeedimetla facility from June 19 to June 23, 2023. The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
“We are proud of the successful completion of the US FDA surveillance inspections at our Vizag and Jeedimetla facilities with zero observations. This achievement is a testament to our unwavering commitment to quality and compliance. It reinforces our position as a trusted and reliable global pharmaceutical manufacturer." said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India.
The Unit IV facility located at Visakhapatnam manufactures Active Pharmaceutical Ingredients (API) and the Jeedimetla facility manufactures Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates (PFIs).
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. 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 seven manufacturing facilities out of which six are in India and one in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
