Granules Life Sciences Private Limited, a wholly owned subsidiary of Granules India Limited, received US Food and Drug Administration (USFDA) approval for its new finished dosage manufacturing facility in Hyderabad. The approval comes for the production of the diabetes drug Metformin HCL, marking a major milestone in the company’s expansion of finished dosage capabilities.
FDA Pre-Approval Inspection Completed Successfully
The approval followed a Pre-Approval Inspection (PAI) conducted by the USFDA from July 28 to August 1, 2025, at the Shamirpet facility on Hyderabad’s outskirts. During the inspection, the USFDA issued a single observation, to which GLS submitted a timely response within the stipulated deadline. This approval officially clears the Shamirpet plant to manufacture up to 10 billion tablets annually, boosting Granules’ production capacity and global market reach.
Expanding Market Presence and Manufacturing Capabilities
“This USFDA approval is a significant achievement, marking the first FDA approval for the GLS Shamirpet facility,” Granules India stated. The company plans to launch Metformin HCL in the US market soon, leveraging this approval to strengthen its presence in the high-demand diabetes treatment segment.
Multi-Site Strategy for Business Continuity
According to Dr. Krishna Chigurupati, Chairman and Managing Director of Granules India, the facility complements the company’s existing Gagillapur plant, which already manufactures Metformin HCL. “The approval of the Shamirpet site allows us to enhance our market share and ensure business continuity through multi-site manufacturing. We also have other products filed from this site and expect USFDA approval for them following necessary audits. This marks the first approval from our second Hyderabad facility with finished dosage capabilities,” Dr. Chigurupati said.
Strengthening Global Competitiveness
The USFDA nod not only expands Granules’ production capacity but also reinforces the company’s commitment to quality, compliance, and global standards. As reported by msn.com, Granules’ multi-site manufacturing and growing product pipeline strengthen its global position. The company is well-equipped to meet rising international demand while maintaining a robust and reliable supply chain.
