In a significant boost to India's pharmaceutical exports, Granules Life Sciences Private Limited (GLS), a wholly-owned subsidiary of Granules India Limited, has secured approval from the United States Food and Drug Administration (USFDA) for its new finished dosage manufacturing facility located in Hyderabad.
Major Regulatory Milestone Achieved
The US drug regulator granted this crucial approval following a successful pre-approval inspection conducted between July 28, 2025, and August 1, 2025. The inspection resulted in only one observation, to which GLS promptly submitted its response within the stipulated timeframe.
This approval specifically covers the manufacturing of diabetes medication Metformin HCL at the company's plant situated in Shammirpet on the outskirts of Hyderabad. The facility boasts an impressive production capacity of 10 billion tablets per annum, positioning it as a significant contributor to Granules India's manufacturing capabilities.
Strategic Expansion and Market Impact
According to Dr. Krishna Chigurupati, Chairman and Managing Director of Granules India Ltd, this approval represents a strategic move to strengthen the company's market position. "Though the same product is already approved and manufactured at our Gagillapur facility, the new plant approval will help us strengthen our market share and support business continuity through multi-site manufacturing," he stated.
Dr. Chigurupati further revealed that this marks the first FDA approval for the GLS site and represents the initial approval from their second Hyderabad facility with finished dosage capabilities. The company has additional products filed from this site and anticipates further USFDA approvals following necessary audits.
Future Plans and Industry Significance
With this regulatory green light, the GLS facility is now officially deemed approved by the USFDA. Granules India has confirmed that GLS plans to launch the approved product in the US market soon, expanding the company's global footprint in the competitive pharmaceutical landscape.
This development not only marks a major milestone for Granules India but also reinforces Hyderabad's position as a key hub for pharmaceutical manufacturing in India. The approval enables the company to enhance its production capabilities while ensuring business continuity through diversified manufacturing locations.
