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Granules India’s arm receives Establishment Inspection Report from USFDA

03 Jun 2026 Evaluate

Granules India’s wholly-owned subsidiary -- Granules Pharmaceuticals, Inc. (GPI) located in Chantilly, Virginia, US has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), with a Voluntary Action Indicated (VAI) classification.

The inspection was conducted from March 30 to April 3, 2026, during which four Form 483 observations were issued. This facility plays an important role in the company’s global manufacturing and supply network, with a continued focus on quality systems, regulatory compliance, and patient safety.

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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