Bliss GVS Pharma Limited has informed the Exchange regarding 'Intimation under Regulation 30 of SEBI (LODR) Regulation, 2015, we would like to inform you that the Rising Pharma Holdings, Inc. USA, a marketing and distribution partner of Bliss GVS Pharma Limited ( the Company ) has been granted final approval from the U.S. Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) for its product Mesalamine Suppositories 1000 mg . The ANDA was submitted through our partner in the USA.'.
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Bliss GVS Pharma's US marketing and distribution partner, Rising Pharma Holdings Inc., has received final approval from the USFDA for an Abbreviated New Drug Application (ANDA) for Mesalamine Suppositories 1000 mg. The application was filed through the partner in the USA. Mesalamine is used in the treatment of ulcerative colitis and inflammatory bowel conditions. This marks the addition of another approved product in the US market through Bliss GVS Pharma's distribution arrangement. The approval enables Rising Pharma to commercially market and distribute the product in the United States.
Positive for shareholders as it expands the product portfolio available in the highly lucrative US generics market via the company's partner, potentially adding to future export earnings in hard currency.