Drugs Pharma

Two Indian firms get FDA nod for drugs to treat ulcerative colitis, fight ammonia

Alembic Glenmark USFDA

HQ Team 

November 2, 2022: Two public Indian pharmaceutical companies have received USFDA approvals for selling drugs meant to treat ulcerative colitis and tablets that aids the body in eliminating substances that produce ammonia.

Alembic Pharmaceuticals got the final nod approval from the US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) for Mesalamine extended-release capsules.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release capsules of Salix Pharmaceuticals, according to a BSE filing.


Mesalamine Extended-Release capsules maintain remission of ulcerative colitis in adults. A label of “ER” or “XR” appears at the end of its name. Medications that have ER forms last longer in your body. 

Mesalamine Extended-Release capsules USP, 0.375 g, have an estimated market size of $133 million for twelve months ending June 2022, according to IQVIA. 

Alembic, one of the top companies in the branded generic market, has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from the USFDA. 


Glenmark Pharmaceuticals Limited has received final approval from the USFDA for its Sodium Phenylbutyrate tablets, the generic version of Buphenyl tablets of Horizon Therapeutics, LLC. 

Glenmark’s tablets will be distributed in the US. by its subsidiary.

 According to IQVIA sales data for the 12 months ending September 2022, the Buphenyl® market2 achieved annual sales of approximately $8.7 million. 

Glenmark’s current portfolio consists of 177 products authorized for distribution in the US marketplace and 46 ANDAs pending approval with the USFDA. “In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.”

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