“We are going to quickly launch this product within the US market. This product is already accepted at our Ghagirapur facility and with this approval we are going to enhance our market share,” Granules India CMD Krishna Prasad Chigurupati stated in a launch. |Picture Credit score: Picture Credit score: www.linkedin.com/in/krishna-prasad-chigurupati
Granules Life Sciences (GLS), a subsidiary of Hyderabad-based generic drug maker Granules India, has acquired US Meals and Drug Administration (US FDA) approval for a product that was topic to pre-approval inspection (PAI) earlier this yr.
The GLS facility has now been deemed cleared by the US FDA, marking a milestone for Granules India in increasing its manufacturing capability for completed formulations. The guardian firm introduced Tuesday (November 11, 2025) that that is the primary FDA approval for a GLS web site. Through the inspection carried out from July 28 to August 1, there was one quotation from the U.S. Meals and Drug Administration. The corporate submitted its response inside the stipulated interval, the corporate stated.
The corporate expects to launch accepted merchandise within the U.S. market quickly. The product has already been accepted and is manufactured at Granules’ Gagillapur facility close to Hyderabad. Granules stated the brand new approval will strengthen the corporate’s market share and assist enterprise continuity by means of multi-site manufacturing, with out specifying the merchandise.
“We are going to quickly launch this product within the US market. This product is already accepted at our Ghagirapur facility and with this approval we are going to enhance our market share,” Granules India CMD Krishna Prasad Chigurupati stated in a launch.
Different merchandise have additionally been submitted from the identical web site and are anticipated to be accepted by the US FDA, topic to mandatory audits, if mandatory. “This improvement marks the primary approval from Granules’ second facility in Hyderabad with end-dose capabilities,” he stated.
