Strides Pharma Science Limited on Monday announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Sevelamer Carbonate Tablets, 800 mg, from the United States Food & Drug Administration (USFDA).
According to the company’s statement, the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Renvela Tablets, 800 mg, of Genzyme. Sevelamer Carbonate is a phosphate binder, that helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.
Sevelamer Carbonate Tablets, 800 mg has a market size of ~US$ 181 Mn as per IMS. This approval further strengthens the Company’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 Sevelamer tablets will be manufactured at the company’s facility in Puducherry.
The company has 260 cumulative ANDA filings (including the recently 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 United States.
