Granules India packaging facility in US successfully completes USFDA inspection

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-12-04 07:22 GMT | Update On 2025-12-04 07:22 GMT

Hyderabad: Granules India has announced that its US step-down subsidiary, Granules Consumer Health, a wholly-owned subsidiary of Granules Pharmaceuticals, has successfully completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations.

This was the facility’s second FDA inspection, following the March 2023 audit that resulted in a No Action Indicated (NAI) classification.

"Granules Consumer Health plays a critical role in our global operations as a packaging and distribution site. We process controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Achieving zero observations in this inspection reflects our unwavering focus on quality, safety, and regulatory excellence," said Dr Krishna Prasad Chigurupati, Chairman and Managing Director of

Granules India.

Read also: Granules India successfully closes acquisition of Swiss based CDMO Senn Chemicals

Granules Consumer Health serves as Granules’ front-end division for OTC products in the U.S., leveraging Granules India’s manufacturing efficiencies, regulatory compliance, and integrated supply chain.

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities. 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 (PFls), 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 and has regulatory approvals from the US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Granules India packaging facility in US successfully completes USFDA inspection

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