drugset / Press release

Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL

2024-05-22 · Halcygen Pharmaceuticals Limited · original strides.com ↗

May 22, 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 Sucralfate Oral Suspension, 1gm/10 mL” Thanks & Regards, For Strides Pharma Science Limited, Manjula Ramamurthy Company Secretary ICSI Membership No. A30515 Encl. As above Press Release May 22, 2024 Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL ▪ Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation ▪ Approval bolsters Strides’ portfolio for the US by adding another differentiated and niche product with limited competition Bangalore, India, May 22, 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 the generic version of Sucralfate Oral Suspension, 1g m/10 mL , from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate® 1gm/10mL of AbbVie. Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, and stomach inflammation and to prevent stress ulcers. Sucralfate Oral Suspension, 1gm/10 mL has a market size o f ~US$ 124Mn as per IQVIA (March 2024). The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at the compan y’s flagship facility in KRS Gardens in Bangalore, India. The company has 260 cumulative ANDA filings (including the acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 2 45+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US. About Sucralfate Sucralfate is a medication that is widely used to prevent and treat a number of diseases in the gastrointestinal tract such as duodenal ulcers Label, gastro -esophageal reflux disease (GERD), gastritis, peptic ulcer disease, stress ulcer, in addition to dyspepsia. It is considered a cytoprotective agent, protecting cells in the gastrointestinal tract from damage caused by agents such as gastric acid, bile salts, alcohol, and acetylsalicylic acid (aspirin), among other substances. 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 ↗