The aforementioned inspection was conducted between 28 July 2025 and 01 August 2025.
There was one observation during that inspection, and the GLS had submitted its response within the stipulated time.
With this approval, the GLS facility is now deemed approved by the U.S. FDA, marking a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site.
The company plans to launch the approved product in the U.S. market soon. The same product is already approved and manufactured at Granules’ Gagillapur facility. The new approval will help strengthen market share and support business continuity through multi-site manufacturing.
Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India, said: “We plan on launching the product into the U.S. market soon. It is an already approved product at our Gagillapur facility, but we plan on building market share with this approval.
We also have other products filed from this site and expect the U.S. FDA to approve them following necessary audits if required. This marks the first approval from our second Hyderabad facility with finished dosage capabilities."
Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).
The company’s consolidated net profit declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 compared with Q2 FY25.
The scrip fell 1.59% to currently trade at Rs 541.40 on the BSE.