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Strides receives USFDA approval for Sevelamer Carbonate for Oral Suspension

Posted On : 2023-09-09 16:02:27( TIMEZONE : IST )

Strides receives USFDA approval for Sevelamer Carbonate for Oral Suspension

Strides Pharma Science Limited (Strides) today announced that its stepdown 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 (USFDA).

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$ 212Mn 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 USFDA, of which 260+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 481.10 as compared to the previous close of Rs. 477.10. The total number of shares traded during the day was 49233 in over 2895 trades.

The stock hit an intraday high of Rs. 490.00 and intraday low of 475.25. The net turnover during the day was Rs. 23733555.00.

Source : Equity Bulls


StridesPharmaScience INE939A01011 StridesPharmaGlobal USFDA Approval SevelamerCarbonate OralSuspension