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Granules India Successfully Completes Two US FDA Audits

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Hyderabad: Granules India Limited, a leading vertically integrated 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 located at Visakhapatnam, Andhra Pradesh, India with zero 483 observations.

Recently, Granules India’s Jeedimetla facility located at Telangana, Hyderabad, India also successfully completed the US FDA’s surveillance inspection with zero 483 observations.

The Vizag facility was inspected by the US FDA from 26th June to 30th June, 2023 and the Jeedimetla facility from 19th June to 23rd June, 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).

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