Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has received its first U.S. Food and Drug Administration (FDA) approval for a product manufactured at its Hyderabad finished-dosage facility. The approval follows a Pre-Approval Inspection (PAI) conducted by the U.S. FDA between July 28 and August 1, 2025.
Granules India disclosed the approval via a corporate press release and regulatory filings to stock exchanges, noting the facility’s FEI number and summarising the PAI timeline and response to the FDA observation. The company said it plans to launch the approved product in the U.S. market “soon.” The same product is already approved and manufactured at the company’s Gagillapur facility, and the new approval will support multi-site manufacturing and business continuity.
The U.S. FDA conducted a Pre-Approval Inspection of the GLS Hyderabad site from 28 July to 1 August 2025. Company disclosures indicate there was one observation from the inspection, and GLS submitted a response within the time stipulated by the FDA. Following the company’s submission, the product and site were deemed acceptable for approval. Corporate filings and media reports echo these details.
A Pre-Approval Inspection is an FDA procedure in which agency inspectors visit manufacturing sites to evaluate compliance with current Good Manufacturing Practices (cGMP) and verify that the facility can manufacture the product as specified in the drug application. Observations raised during such inspections require a written response; if the response and corrective actions are satisfactory to the FDA, the product and site can be approved for the U.S. market.
Granules India has multiple facilities and a history of manufacturing both active pharmaceutical ingredients and finished-dosage forms. The company has previously obtained U.S. regulatory clearances for other products from its Gagillapur facility and has undergone inspections for various plants in its group. The Hyderabad GLS approval represents the first FDA approval specifically for that finished-dosage site.
Granules India is a vertically integrated, high-growth pharmaceutical company with over 40 years of proven performance and a steadily expanding global footprint. Headquartered in Hyderabad, India, the company partners with leading pharmaceutical organizations worldwide, offering high-quality Active Pharmaceutical Ingredients (API), Pharmaceutical Formulation Intermediates (PFI), and Finished Dosages (FD). Granules India emphasizes manufacturing excellence, process innovation, and regulatory compliance to deliver reliable, cost-effective healthcare solutions through strategic global collaborations.
(Rh/TL)
