Strides Pharma Science Ltd’s shares were up by 0.76 per cent after the company said its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, had received approval from the United States Food & Drug Administration (USFDA) for the generic version of Sucralfate Oral Suspension, 1gm/10 mL.
This is the first Indian approval for this formulation by the USFDA. Sucralfate Oral Suspension is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Carafate 1gm/10mL of AbbVie. The medication is used to treat conditions such as stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, and stomach inflammation, and to prevent stress ulcers.
The Sucralfate Oral Suspension, 1gm/10 mL has a market size of approximately $124 million as per IQVIA (March 2024). The product will be manufactured at Strides’ flagship facility in KRS Gardens, Bengaluru. Strides has 260 cumulative ANDA filings with the USFDA, including the acquired portfolio from Endo at Chestnut Ridge, with over 245 ANDAs approved. The company aims to launch around 60 new products in the US over the next three years.
The shares were up 1.25 per cent at ₹856.75 at 11.23 am on the BSE.