USFDA concludes audit at Granules' arm facility with zero observations

21 Mar 2023 Evaluate

U.S. Food and Drug Administration (US FDA) has concluded the audit at Granules India’s stepdown subsidiary -- Granules Consumer Health Inc (GCH) facility with zero observations. The facility was inspected by the US FDA from March 15, 2023 to March 20, 2023. The audit is a pre-approval inspection for three products filed from the facility. Granules Consumer Health is a leading private-label OTC provider, and its packaging facility will enable it to service leading retailers more effectively.

The packaging facility in Manassas is spread over 79,000 sq ft and has several packaging suites to service customer needs. Granules Consumer Health (GCH) was established in 2014, to offer OTC generics that meet the highest level of quality at an affordable cost.

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).

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