Strides Pharma Secures US FDA Nod for Sevelamer Carbonate Tablets, 800 mg

On May 10, 2024, Strides Pharma Science Limited informed the stock exchanges that the company’s step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, got approval for Sevelamer Carbonate Tablets, 800 mg, from the United States Food & Drug Administration (US FDA).

The company stated that the product is therapeutically equivalent and bioequivalent to the Reference Listed Drug (RLD), Renvela® Tablets, 800 mg, of Genzyme. Sevelamer Carbonate is a phosphate binder that helps in preventing hypocalcemia, i.e., low levels of calcium in the body. This hypocalcemia is caused by elevated phosphorus.

Sevelamer Carbonate Tablets, 800 mg, has a market size of ~US$ 181 million as per IMS. This approval further bolsters Strides Pharma Science’s presence in the Sevelamer portfolio, complementing the existing approval of Sevelamer Carbonate Powder for Oral Suspension, which has a market size of US$23 Mn.

The company stated that the Sevelamer tablets will be manufactured at their manufacturing facility located in Puducherry, Tamil Nadu.

Strides Pharma Science has 260 cumulative Abbreviated New Drug Application (ANDA) filings, which includes their newly acquired portfolio from Endo at Chestnut Ridge with the US Food & Drug Administration, of which more than 245 ANDAs have been approved. The company has set a target to launch approximately 60 new products in the United States over three years.

The company specified in their exchange filing that Sevelamer Carbonate is a medication used to control high levels of phosphate in the blood of a person with chronic kidney disease. When consumed after a meal, the medication attaches to dietary phosphate and prevents its absorption, thereby controlling overall phosphate levels in the blood.

About Strides Pharma Science Limited

Strides Pharma Science Limited is a multinational pharmaceutical company with divisions focusing on Regulated Markets and Emerging Markets. The company operates eight manufacturing units across four continents, including five US FDA-approved facilities, and maintains a robust R&D centre in India with worldwide filing capabilities, serving more than 100 countries.

On May 10, 2024, the share price of Strides Pharma Science Ltd opened at ₹834.00, touching the day’s high at ₹857.60, as of 12:55 PM on the NSE.

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