Bliss GVS Pharma Limited has issued an official clarification confirming that its marketing and distribution partner in the United States, Rising Pharma Holdings Inc., has received final approval from the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) of Mesalamine Suppositories 1000 mg.
The company highlighted that the approval was obtained through its partner and falls under the regulatory compliance of SEBI (Listing Obligations and Disclosure Requirements), 2015. The product addresses a niche therapeutic area with an estimated market size of USD 29 million for the 12 months ending January 2025, as per IQVIA data.
Managing Director Gagan Harsh Sharma stated that this approval reflects the company’s growing in-house R&D capabilities and enhances its U.S. portfolio of both OTC and prescription products.
The company reiterated that all information has been disclosed in accordance with regulatory norms and requested the exchanges to disseminate the announcement to the public.
