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Strides receives US FDA approval for sevelamer carbonate for oral suspension

Our Bureau, Bengaluru
Monday, September 11, 2023, 15:40 Hrs  [IST]

Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for sevelamer carbonate for oral suspension USP, 0.8g and 2.4g, from the United States Food & Drug Administration (FDA).
 
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Renvela for oral suspension, 0.8g and 2.4g of Genzyme. The approval completes the company's sevelamer carbonate portfolio.
 
The sevelamer carbonate market for both tablets and oral suspension has a combined opportunity of ~US$ 212 million per IQVIA. The products will be manufactured at the company’s facility in Bengaluru. The product is a complex generic with limited players having both the tablets and oral suspension.
 
The company has 280 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with US FDA, of which 260+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.
 
Sevelamer carbonate for oral suspension 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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