Strides receives USFDA approval for Levetiracetam Oral Solution
2023-11-21 · Halcygen Pharmaceuticals Limited · original strides.com ↗
November 21, 2023 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 Levetiracetam Oral Solution” Thanks & Regards, For Strides Pharma Science Limited, Manjula Ramamurthy Company Secretary ICSI Membership No. A30515 Encl. As above Press Release Nov 21, 2023 Strides receives USFDA approval for Levetiracetam Oral Solution Bangalore, India, November 21, 2023 ‐ Strides Pharma Science Limited (Strides) today announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Levetiracetam Oral Solution USP, 100 mg/mL, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc. It is used in the treatment of seizures. The Levetiracetam Oral Solution has a market size of ~US$55 Mn per IQVIA. The product will be manufactured at the company’s facility in Bengaluru. The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US. 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), Singapore, 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 Fortuna PR K Srinivas Reddy: +91 90005 27213 [email protected] Boni Mukherjee: +91 96186 82208 [email protected]
The release as fetched from its publisher. strides.com ↗