Strides Pharma Science Limited announced on Wednesday that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has obtained approval from the United States Food & Drug Administration (USFDA) for its generic version of Sucralfate Oral Suspension, 1gm/10 mL. The company stated that this product is both bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate 1gm/10mL, produced by AbbVie.
Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, stomach inflammation, and to prevent stress ulcers.
According to IQVIA (March 2024), the market size for Sucralfate Oral Suspension, 1gm/10 mL, is approximately US$ 124 million. This formulation will be produced at the company’s flagship facility in KRS Gardens, Bangalore, India.
Strides Pharma Science Limited has a total of 260 cumulative ANDA filings with the USFDA, including the acquired portfolio from Endo at Chestnut Ridge, with over 245 of these ANDAs approved. The company aims to launch around 60 new products in the United States over the next three years.