Granules India’s US step-down subsidiary -- Granules Consumer Health, LLC has received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) Status from the US Food and Drug Administration (FDA) for its packaging facility in Manassas, Virginia, U.S.
The FDA inspection was conducted at the company’s packaging facility in Manassas, Virginia, from December 1 to 3, 2025. This marks the facility’s second FDA inspection, following the March 2023 audit, which also concluded with zero observations.
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. This facility is responsible for packaging both OTC and prescription (Rx) products and serving as a distribution hub for OTC products across the US.
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).
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1824.10 |
| Dr. Reddys Lab | 1287.95 |
| Cipla | 1334.85 |
| Zydus Lifesciences | 901.65 |
| Lupin | 2350.95 |
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