By: IPP Bureau
Last updated : May 29, 2024 10:59 am
Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation
Strides Pharma Science Limited (Strides) announced that its step-down 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.
Sucralfate Oral Suspension, 1gm/10 mL has a market size of ~US$ 124 million 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.