Granules Life Sciences has successfully completed a Pre-Approval Inspection (PAI) by the US FDA for its Hyderabad-based facility, with just one procedural observation that has been resolved. This milestone enhances the company's position in the competitive US pharmaceutical market and supports future product approvals.
Granules Life Sciences Private Limited, a wholly owned subsidiary of Granules India, announced that its Hyderabad facility at Shamirpet Mandal has received significant regulatory validation from the US FDA. The Pre-Approval Inspection (PAI), conducted between July 28 and August 1, 2025, concluded with a single observation, which the company promptly addressed within the stipulated timeframe.
The facility manufactures pharmaceutical formulation intermediates and finished dosages, reflecting Granules’ integrated capabilities across the pharmaceutical value chain. This approval is not just a regulatory success but a testament to the company's commitment to quality, operational excellence, and adherence to global standards.
Granules India has a diversified manufacturing footprint with multiple facilities in India and the USA, and this approval bolsters confidence among stakeholders looking for high-quality, compliant manufacturing partners.
The ongoing focus on regulatory compliance and quality assurance is anticipated to accelerate Granules’ growth trajectory in regulated markets, including expanded opportunities for first-to-file controlled substance Abbreviated New Drug Applications (ANDAs).
Key Highlights:
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US FDA completed Pre-Approval Inspection at Hyderabad (Shamirpet) facility July-August 2025
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One procedural observation issued and successfully resolved by Granules Life Sciences
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Facility produces pharmaceutical intermediates and finished dosages for global markets
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Strengthens Granules’ competitive position in US pharmaceutical and controlled substances market
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Reflects Granules’ commitment to global regulatory compliance and quality manufacturing standards
Sources: Medical Dialogues, NSE India filings, CNBC-TV18, Granules India official communications