Hyderabad: Granules India Limited, a leading pharmaceuticals player based in Hyderabad, has announced its maiden USFDA approval for its Hyderabad facility, following its response to one observation that the FDA had made during its inspection. The company’s wholly owned subsidiary, Granules Life Sciences Limited, has received this approval, marking a major milestone for the company as it looks to expand its finished dosage capabilities.
The approved product is already being manufactured at Granules’ Gagillapur facility, and this development would help the company expand its market share and support its business through multi-site manufacturing.
“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,” said Dr. Krishna Prasad Chigurupati, Chairman & MD, Granules India Limited.
“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.”
About Granules India
Founded in 1991, Granules India is a vertically integrated pharmaceutical manufacturer, mainly known for the production of off-patent drugs like Paracetamol, Ibuprofen, Guaifenesin and Metformin, has been one of the leading pharmaceutical firms in India. Over the years, it has expanded its production to include seven manufacturing units, including one in China with its JV partner.
