Strides Pharma Receives US FDA Approval for Generic Renvela Tablets
Overview
Strides Pharma Science’s step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval for sevelamer carbonate tablets, 800 mg, from the United States Food & Drug Administration (FDA).
Sevelamer Carbonate & Genzyme
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 hypocalcaemia (low levels of calcium in the body) caused by elevated phosphorus.
Total Market Size
Sevelamer carbonate tablets, 800 mg has a market size of ~US$ 181 million 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 million.
The sevelamer tablets will be manufactured at the company’s facility in Puducherry.
ANDA Filings
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with US FDA, of which 245+ ANDAs have been approved.
The company has set a target to launch ~ 60 new products over three years in the US.
Sevelamer Carbonate
Sevelamer carbonate 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.
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