NSEPress Release26 Jun 2026 · 26 Jun 2026, 09:38 am

Press Release

Lupin Limited · LUPIN

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Lupin Limited has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Enzalutamide Tablets, providing alternative dosing options for healthcare providers and patients.

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Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
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 Jun 26, 2026, titled "Lupin Receives Tentative Approval from U.S. FDA for Enzalutamide Tablets".

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Lupin2_26062026093446_SELetterPressRelease.pdf

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June 26, 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 Tentative Approval from U.S. FDA for Enzalutamide Tablets”. 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 Tentative Approval from U.S. FDA for Enzalutamide Tablets Mumbai, India, Naples, Fla, June 26, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg. The U.S. FDA has tentatively approved Lupin’s Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to reference listed drug (RLD) Xtandi® Tablets of Astellas for the indication in the approved labeling. While Xtandi Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin’s tentatively approved 120 mg and 160 mg strengths will provide healthcare providers and patients with alternative dosing options. About Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. 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 Xtandi is a registered trademark of Astellas Pharma Inc. Page 1 of 1