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STRIDES PHARMA SCIENCE LIMITED — Capital/Financing Update 2023
Oct 3, 2023
62616_rns_2023-10-03_0c4acfea-83d9-4b65-b885-e57136b15129.pdf
Capital/Financing Update
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October 3, 2023
BSE Limited The National Stock Exchange of India Limited Phiroze Jeejeebhoy Towers, Exchange Plaza, Bandra-Kurla Complex Dalal Street, Mumbai – 400 001 Bandra (E) Mumbai - 400 051 Scrip code: 532531 Scrip code: STAR
Dear Madam/ Sir,
Sub: Updated Press Release
This has reference to the Press Release issued by the Company on September 23, 2023 titled as “Strides receives USFDA approval for Icosapent Ethyl Capsules”
The said press release has been updated with some additional information on the Product and the revised Press release is attached herewith for your records.
Thanks & Regards,
For Strides Pharma Science Limited,
Digitally signed by MANJULA MANJULA RAMAMURTHY RAMAMURTHY Date: 2023.10.03 15:24:23 +05'30'
Manjula Ramamurthy Company Secretary ICSI Membership No. A30515
Encl. As above
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Updated Press Release October 03, 2023
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Strides receives USFDA approval for Icosapent Ethyl Capsules
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Product marks another successful first cycle approval for the company
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Significant market opportunity with ~USD 1.3Bn sales as per IQVIA
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To be introduced into the market immediately in partnership with a leading generic company
Bangalore, India, Oct 03, 2023 ‐ Strides Pharma Science Limited (Strides) on September 23, 2023 announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram, from the United States Food & Drug Administration (USFDA). The product complements Strides’ range of approved soft gelatin capsules.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin®. The Icosapent Ethyl Capsules has a market size of ~USD 1.3Bn 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 Icosapent Ethyl Capsule
Strides’s Icosapent Ethyl Capsules is approved for the following indication: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Strides’s Icosapent Ethyl Capsules is not approved for the following indication: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.
Limitations of Use : The effect of Icosapent Ethyl Capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
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:
| StridesBadree KomandurExecutive Director – Finance & Group CFO+91 80 6784 0747Strides Pharma Science LimitedCIN: L24230MH1990PLC057062Regd. Office: 201, ‘Devavrata’, Sector ‐ 17, Vashi,Navi Mumbai ‐ 400 703Corp. Office: Strides House, Bannerghatta Road,Bengaluru – 560076 | Corporate CommunicationPallavi Panchmatia:+91 80 6784 0193Email: [email protected]PR ConsultancyFortuna PRK Srinivas Reddy: +91 90005 27213[email protected] Boni Mukherjee: +91 96186 82208[email protected] |
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