NSEPress Release1d ago · 4 Sept 2026, 05:38 pm

Press Release

Lupin Limited · LUPIN

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Lupin Limited has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg, with estimated annual sales of USD 70.7 million in the U.S.

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Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
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Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10

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Lupin Limited has informed the Exchange regarding a press release dated September 04, 2026, titled "Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP".

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September 04, 2026 National Stock Exchange of India Limited BSE Limited Exchange Plaza, P. J. Towers, Dalal Street, Bandra Kurla Complex, Mumbai Samachar Marg, Bandra (East), Mumbai - 400 001 Mumbai - 400 051 Symbol: LUPIN Scrip Code: Equity - 500257 Subject: Disclosure pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 Dear Sir/Madam, We are pleased to enclose a Press Release titled “Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP”. The same is for your information and dissemination. Thanking you, For LUPIN LIMITED AMIT KUMAR GUPTA COMPANY SECRETARY & COMPLIANCE OFFICER (ACS -15754) Encl.: a/a. LUPIN LIMITED Registered Office: 3rd Floor, Kalpataru Inspire, Off W. E. Highway, Santacruz (East), Mumbai - 400 055 India. Tel: (91-22) 6640 2323. Corporate Identity Number: L24100MH1983PLC029442 info@lupin.com | www.lupin.com Press Release BSE: 500257 NSE: LUPIN REUTERS: LUPIN.BO BLOOMBERG: LPCIN Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP Mumbai, India, Naples, Fla, September 4, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg. The U.S. FDA has approved Lupin’s Modafinil Tablets USP, 100 mg and 200 mg as bioequivalent to the reference listed drug (RLD), Provigil® Tablets of Nuvo Pharmaceuticals (Ireland) DAC, and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD). Modafinil Tablets (RLD Provigil®) had estimated annual sales of USD 70.7 million in the U.S. (IQVIA MAT Jul 2026). About Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, with products distributed in over 100 markets. Lupin has a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars, and continues to strengthen its market position through a differentiated portfolio. The company maintains strong leadership in the U.S. and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women’s health. 15 state-of-the-art manufacturing facilities support sustainable operations, with 6 research centers and a dedicated workforce of over 26,000 professionals. Lupin continues to expand the healthcare ecosystem through diagnostics, digital health, patient-support programs, and disease management initiatives. Sustainability continues to be a core pillar of the company’s business strategy. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin For further information or queries please contact: Rajalakshmi Azariah Vice President & Global Head – Corporate Communications, Lupin rajalakshmiazariah@lupin.com Elise Titan Director – U.S. Communications, Lupin elisetitan@lupin.com *Safe Harbor Statement Provigil is the registered trademark of Nuvo Pharmaceuticals (Ireland) DAC Page 1 of 1