Strides Pharma Science arm gets USFDA nod for Hypocalcemia drug Sevelamer Carbonate
Sevelamer Carbonate is a phosphate binder, that helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.
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 Tablets, 800 mg, from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Renvela Tablets, 800 mg, of Genzyme.
Sevelamer Carbonate is a phosphate binder, that helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus. Sevelamer Carbonate 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.
Sevelamer Carbonate Tablets, 800 mg has a market size of ~US$ 181 Mn as per IMS. This approval further strengthens the Company's presence in the Sevelamer portfolio, complementing the existing approval of Sevelamer Carbonate Powder for Oral Suspension, which has a market size of US$23 Mn.
The Sevelamer tablets will be manufactured at the company’s facility in Puducherry.
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 245+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.
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Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) 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 donor‐ funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York).
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