Home / Business and Economy / Granules India's Hyderabad Facility Earns First USFDA Approval
Granules India's Hyderabad Facility Earns First USFDA Approval
11 Nov
Summary
- Granules Life Sciences (GLS) receives first USFDA approval for Hyderabad facility
- Approval for a product after pre-approval inspection in July-August 2025
- Approval marks milestone as Granules expands finished dosage manufacturing
On November 11, 2025, Granules Life Sciences (GLS), an arm of Granules India, announced that it has received its first approval from the US Food and Drug Administration (USFDA) for its Hyderabad facility. This approval, granted after a pre-approval inspection (PAI) conducted by the US drug regulator between July 28 and August 1, 2025, is a significant milestone for the company as it expands its finished dosage manufacturing capabilities.
During the PAI, the USFDA had issued one observation, which GLS had promptly addressed by submitting its response within the stipulated time. With this approval, the GLS facility in Hyderabad is now deemed approved by the USFDA. The company plans to launch the approved product in the US market soon, as the same product is already approved and manufactured at Granules' Gagillapur facility.
According to Krishna Prasad Chigurupati, the Chairman and Managing Director of Granules India, this approval will help strengthen the company's market share and support business continuity through multi-site manufacturing. Granules also has other products filed from the Hyderabad site and expects the USFDA to approve them following necessary audits, if required.
