USFDA approves Strides Pharma Global stomach ulcer treatment drug

Bangalore: Strides Pharma Science Limited has announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the United States Food & Drug Administration (USFDA).

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 and to prevent stress ulcers. It is considered a cytoprotective agent, protecting cells in the gastrointestinal tract from damage caused by agents such as gastric acid, bile salts, alcohol, and acetylsalicylic acid (aspirin), among other substances.

Sucralfate Oral Suspension, 1gm/10 mL has a market size of ~US$ 124Mn as per IQVIA (March 2024). The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India.

The company has 260 cumulative ANDA filings (including the acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 245+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.

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Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donorfunded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries

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