Last Updated on September 14, 2023 by The Health Master
Strides Pharma Science Ltd., through its subsidiary Strides Pharma Global Pte Ltd Singapore, has achieved a significant milestone with USFDA approval from the US Food & Drug Administration (USFDA) for its generic Sevelamer Carbonate oral suspension.
This development is poised to revolutionize the treatment of chronic kidney disease in patients undergoing dialysis, preventing dangerous spikes in phosphate levels.
USFDA Approval for Multiple Strengths:
Equivalent to Renvela:
The newly approved product is both bioequivalent and therapeutically equivalent to the reference-listed drug, Renvela for Oral Suspension, in its 0.8g and 2.4g variants.
This endorsement attests to the quality and efficacy of Strides‘ formulation.
Completing the Sevelamer Carbonate Portfolio:
Notably, this achievement is particularly significant as the product is classified as a complex generic, an area with a limited number of market players offering both tablet and oral suspension versions.
Manufacturing Hub in Bengaluru:
According to data from IQVIA, the combined market opportunity for Sevelamer Carbonate in both tablet and oral suspension forms is estimated at a substantial USD 212 million.
This indicates a robust demand for the product, which Strides is now poised to meet.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: