Granules India Completes cGMP Audit at Chantilly Site
Granules India Limited announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, US, successfully completed a routine current Good Manufacturing Practices (cGMP) audit by the US Food and Drug Administration (FDA). The inspection took place from March 30 to April 3, 2026.The FDA audit resulted in four Form 483 observations. The reported observations were related to procedural matters, and the inspection did not yield any data integrity related observations.
Granules stated its continued commitment to maintaining the highest standards of quality, safety, and regulatory compliance, confirming it will address the observations raised by the US FDA within the stipulated timelines.
Granules India Limited, which was incorporated in 1991, is described as a vertically integrated fast growing Indian pharmaceutical company. Headquartered in Hyderabad, the company operates out of best-in-class facilities. Granules has a presence in the manufacturing of the entire value chain, encompassing Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages (FDs), and Peptides CDMO.
The company distributes its products to over 300+ customers in both regulated and semi-regulated markets. Its global footprint extends to over 80+ countries, with offices situated across India, the US, and Switzerland.
Granules operates 10 manufacturing facilities: seven located in India, two in the USA, and one in Switzerland. The company holds regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
A look at the facilities and approvals:
| Location | Number of Facilities |
|---|---|
| India | 7 |
| USA | 2 |
| Switzerland | 1 |
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