India Pharma Outlook Team | Tuesday, 11 November 2025
Granules India announced that its subsidiary, Granules Life Sciences (GLS), based in Hyderabad, has obtained approval from the U.S. Food and Drug Administration (FDA) for a product that underwent a pre-approval inspection (PAI).
The inspection in question took place from 28 July 2025 to 01 August 2025. During this inspection, one observation was noted, and GLS submitted its response within the required timeframe. With this approval, the GLS facility is now recognized as approved by the U.S. FDA, representing a significant achievement for Granules India as it enhances its finished dosage manufacturing capabilities. This marks the first FDA approval for the GLS site.
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The company intends to introduce the approved product into the U.S. market shortly. This product is already approved and produced at the Granules Gagillapur facility. The new approval is expected to bolster market share and ensure business continuity through multi-site manufacturing.
Dr. Krishna Prasad Chigurupati, chairman and managing director of Granules India, stated: "We plan to launch the product in the U.S. market soon. It is already approved at our Gagillapur facility, but we aim to increase market share with this new approval." Additionally, we have other products submitted from this site and anticipate that the U.S. FDA will approve them following any necessary audits.
This represents the first approval from our second facility in Hyderabad, which has finished dosage capabilities. Granules India primarily focuses on the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). In Q2 FY26, the company's consolidated net profit fell by 16.3% to Rs 112.64 crore, while net sales rose by 3.4% to Rs 1,208.79 crore compared to Q2 FY25. The stock price decreased by 1.59%, currently trading at Rs 541.40 on the BSE.
