Strides receives USFDA approval for Sevelamer Carbonate Tablets, 800 mg
2024-05-10 · Halcygen Pharmaceuticals Limited · original strides.com ↗
May 10, 2024 BSE Limited Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai – 400 001 Scrip code: 532531 The National Stock Exchange of India Limited Exchange Plaza, Bandra-Kurla Complex Bandra (E) Mumbai - 400 051 Scrip code: STAR Dear Madam/ Sir, Sub: Press Release Please find attached Press Release issued by the Company titled: “Strides receives USFDA approval for Sevelamer Carbonate Tablets, 800 mg” Thanks & Regards, For Strides Pharma Science Limited, Manjula Ramamurthy Company Secretary ICSI Membership No. A30515 Encl. As above Press Release May 10, 2024 Strides receives USFDA approval for Sevelamer Carbonate Tablets, 800 mg Sevelamer Carbonate Tablets approval consolidates the Company's position in the Sevelamer segment by complementing the existing approval of Sevelamer for Oral Suspension Bangalore, India, May 10, 2024 - Strides Pharma Science Limited (Strides) today announced that its step- down 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 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. About Sevelamer Carbonate 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. About Strides 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). The Company focuses on “difficult to manufacture” products sold in over 100 countries. Additional information is available at the Company’s website at www.strides.com. For further information, please contact: Strides Badree Komandur Executive Director – Finance & Group CFO +91 80 6784 0747 Strides Pharma Science Limited CIN: L24230MH1990PLC057062 Regd. Office: 201, ‘Devavrata’, Sector - 17, Vashi, Navi Mumbai - 400 703 Corp. Office: Strides House, Bannerghatta Road, Bengaluru – 560076 Corporate Communication Pallavi Panchmatia: +91 80 6784 0193 Email: [email protected] PR Consultancy Adfactors PR Janhavi Bellare: +91 93228 54508 [email protected]
The release as fetched from its publisher. strides.com ↗