Strides Pharma Science subsidiary gets USFDA nod for Sucralfate oral suspension, stock jumps 7%

The firm said that the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Carafate 1gm/10mL of AbbVie. Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, and stomach inflammation as well as to prevent stress ulcers.

Strides Pharma Science said that this marks the first Indian approval from the USFDA for this complex formulation. The approval bolsters the firm's portfolio for the US by adding another differentiated and niche product with limited competition, the company said in an exchange filing.

Sucralfate Oral Suspension, 1gm/10 mL has a market size of about $124 million as per IQVIA (March 2024). Sucralfate is a medication that is widely used to prevent and treat several diseases in the gastrointestinal tract such as duodenal ulcers Label, GERD, gastritis, peptic ulcer disease, stress ulcer, in addition to dyspepsia. The drug will be manufactured at the company’s flagship facility in KRS Gardens in Bengaluru, India.

Strides Pharma Science has 260 cumulative abbreviated new drug application (ANDA) filings, including the acquired portfolio from Endo at Chestnut Ridge, with the USFDA. Of this, over 245 ANDAs have been approved, it said. The company has set a target to launch about 60 new products over three years in the US.

The company is headquartered in Bengaluru and has manufacturing sites in Chennai, Puducherry, and two locations in Bengaluru, Italy, Kenya, and the United States.

Shares of the company have gained over 38% since the beginning of the year. The stock has gained nearly 153% in the last one year.