Sun Pharma Announces US FDA Approval for Generic Lenalidomide Capsules
2023-02-10 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗
Sun Pharmaceutical Industries Limited SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA. Reaching People. Touching Lives. FOR IMMEDIATE RELEASE Sun Pharma Announces US FDA Approval for Generic Lenalidomide Capsules Mumbai, India , February 10, 202 3: Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies), today announced that one of its wholly owned subsidiaries has received final approval from US FDA for its Abbreviated N ew Drug Application (ANDA) for generic lenalidomide Capsules, 5mg, 10mg, 15mg, 2 5mg and tentative approval for 2.5mg, 20mg . The respective product approval is based on Revlimid® Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product. In June 2021, Sun Pharma had entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding Sun Pharma’s generic lenalidomide capsules. Pursuant to the terms of this settlement, Celgene grant ed Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the US beginning sometime after March 2022. In addition, the license allows Sun Pharma to manufacture and sell an unlim ited quantity of generic lenalidomide capsules in the US beginning January 31, 2026. ® - All brand names and trademarks are the property of respective owners Disclaimer: Statements in this Document describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the interpretations of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments or circumstances after the date hereof. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world 's fourth largest specialty generic pharmaceutical company and India's largest pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high -quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved b y multiple regulatory agencies, coupled with a multi -cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R &D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter@SunPharma_Live. Contacts Investors Media Dr. Abhishek Sharma Gaurav Chugh Tel + 91 22 4324 4324, Ext 2929 Tel + 91 22 4324 4324, Ext 5373 Tel Direct + 91 22 43242929 Tel Direct + 91 22 43245373 Mobile + 91 98196 86016 Mobile + 91 98104 71414 E mail [email protected] E mail [email protected]
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