Strides Pharma Secures US FDA Approval for Generic Sucralfate Oral Suspension

On May 22, 2024, Strides Pharma Science Limited (Strides) informed in an exchange filing that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has got a nod from the United States Food & Drug Administration (US FDA) for the generic version of Sucralfate Oral Suspension, 1gm/10 mL.

Sucralfate Oral Suspension is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate® 1gm/10mL of AbbVie. Sucralfate is used in the treatment of stomach ulcers, radiation proctitis, stomach inflammation, gastroesophageal reflux disease (GERD) and to prevent stress ulcers. The medication acts as a cytoprotective agent, shielding gastrointestinal cells from harm induced by various substances like gastric acid, bile salts, alcohol, and acetylsalicylic acid (aspirin).

The company stated that as per IQVIA, as of March 2024, Sucralfate Oral Suspension, 1gm/10 mL, has a market size of ~US$124 million. The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at Strides Pharma Science Limited’s flagship facility in KRS Gardens in Bangalore, India.

The company further added that Strides’ approval for this product represents the first Indian approval from the US FDA for this complex formulation. This approval enhances the company’s US portfolio by introducing another unique, specialised product with minimal competition.

The company has 260 cumulative ANDA filings, including the acquired portfolio from Endo at Chestnut Ridge with the United States Food & Drug Administration, of which more than 245 ANDAs have been approved. The company has set a target to launch approximately 60 new products over three years in the United States.

Earlier this month, the same subsidiary of the company, Strides Pharma Global Pte. Limited, Singapore, got approval for Sevelamer Carbonate Tablets, 800 mg, from the United States Food & Drug Administration.

The approval of Sevelamer Carbonate Tablets, 800 mg, with a market size of approximately US$181 million, according to IMS, reinforces the company’s position in the Sevelamer portfolio. This approval complements the existing approval for Sevelamer Carbonate Powder for Oral Suspension, which has a market size of US$23 million. The Sevelamer tablets will be produced at the company’s facility in Puducherry.

About Strides Pharma Science Limited

Strides Pharma Science is a global pharmaceutical company headquartered in Bengaluru, India. The company primarily operates within regulated markets and adopts an “in Africa for Africa” approach. It also has an institutional business dedicated to serving donor-funded markets. Its global manufacturing facilities are situated in various locations, including India, Italy, Kenya, and the United States.

On May 22, 2024, the share price of Strides Pharma Science Ltd opened at ₹851.50, touching the day’s high at ₹862.80, as of 11:29 AM on the NSE.

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