Strides Receives USFDA Approval for Sevelamer Carbonate for Oral Suspension
- This approval compliments Strides’ acquired Sevelamer Carbonate tablets ANDA expected to be commercialized in Q1FY25.
- The Sevelamer Carbonate Oral Suspension to be introduced into the market immediately
Sevelamer Carbonate for Oral Suspension
Strides Pharma Global, a subsidiary of Strides Pharma Science Limited, has received approval from the US Food & Drug Administration (USFDA) for Sevelamer Carbonate for Oral Suspension USP, 0.8g and 2.4g.
The medication is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Renvela for Oral Suspension, 0.8g and 2.4g of Genzyme, and completes Strides’ Sevelamer Carbonate portfolio. The total combined opportunity for the Sevelamer Carbonate market for both tablets and oral suspension is estimated to be around $212Mn per IQVIA. Strides plans to manufacture the products at their facility in Bengaluru. The company has a target of launching approximately 60 new products over three years in the US and has over 280 cumulative ANDA filings with the USFDA, of which 260+ have been approved.
About Sevelamer Carbonate for Oral Suspension
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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