Strides Pharma Science Singapore arm gets USFDA nod for Sevelamer Carbonate for Oral Suspension
Bangalore: Strides Pharma Science Limited has 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.
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.
Read also: Strides Singapore arm bags USFDA nod for Mycophenolate Mofetil for Oral Suspension
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donorfunded markets.
The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York).
Read also: Strides Pharma Science biologics arm to divest Unit 3 multi modal facility to Syngene International for Rs 702 crore
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