Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration (USFDA).
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.
It is a medication used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease. When consumed after a meal, the medication binds to dietary phosphate and prevents its absorption thereby managing overall phosphate levels in the blood.
Sevelamer Carbonate Tablets, 800 mg has a market size of approximately $181 million as per IMS. 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 reportedly has set a target to launch approximately 60 new products over three years in the US.