Granules Life Sciences (GLS), a wholly owned subsidiary of Granules India, has achieved a significant regulatory milestone with its first US Food and Drug Administration (FDA) approval for its Hyderabad manufacturing facility. The approval follows a pre-approval inspection (PAI) conducted between July 28 and August 1, 2025.
Regulatory Milestone Achievement
The FDA inspection resulted in one observation, to which GLS submitted its response within the stipulated timeframe. With this approval, the GLS facility is now deemed approved by the US FDA, representing a major advancement for Granules India as it expands its finished dosage manufacturing capabilities.
"We plan on launching the product into the US market soon. It is an already approved product at our Gagillapur facility, but we plan on building market share with this approval," said Dr. Krishna Prasad Chigurupati, chairman and managing director of Granules India Limited.
Strategic Manufacturing Expansion
The new approval enables multi-site manufacturing capabilities for Granules India, as the same product is already approved and manufactured at the company's Gagillapur facility near Hyderabad. This dual-site approval strategy is designed to strengthen market share and support business continuity through diversified manufacturing operations.
The company has not disclosed the specific product that received approval but indicated plans for an imminent US market launch. This development marks the first approval from Granules' second Hyderabad facility with finished dosage capabilities.
Future Pipeline Prospects
Beyond the current approval, GLS has additional products filed from the Hyderabad site. "We also have other products filed from this site and expect the US FDA to approve them following necessary audits if required," Chigurupati added.
The regulatory success positions Granules India to leverage its expanded manufacturing footprint in the competitive US generic pharmaceutical market, with the potential for additional approvals from the same facility pending future FDA audits.
