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USFDA completes GMP inspection at packaging facility of Granules India’s arm

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

U.S. Food and Drug Administration (USFDA) has successfully completed a GMP inspection at packaging facility of Granules India’s US step-down subsidiary -- Granules Consumer Health, LLC 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 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 is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).