By: IPP Bureau
Last updated : April 16, 2025 9:41 am
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
Rising Pharma Holdings, USA, a marketing and distribution partner of Bliss GVS Pharma Limited 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.
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million for the twelve months ending January 2025, according to IQVIA.
"The ANDA approval for Mesalamine suppositories further strengthens our portfolio of differentiated OTC and Prescription products for the U.S. market. This approval is a testament to our capabilities to successfully develop and commercialize products using in-house R&D capabilities built over the last few years," commented Gagan Harsh Sharma, Managing Director, Bliss GVS Pharma Limited.