USFDA approves Strides Pharma Global stomach ulcer treatment drug
Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease, radiation proctitis, and stomach inflammation and to prevent stress ulcers.;
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.
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