BSECompany Update4d ago · 31 Jul 2026, 05:06 pm

Lupin Announces the approval of Diazepam Injection, USP in the United States.

Lupin Ltd · 500257

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Lupin Ltd has received approval from the US FDA for its Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes, with estimated annual sales of USD 77.9 million in the U.S.

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Earnings Impact8/10
Growth Catalyst6/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment8/10

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Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

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July 31, 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 Announces the Approval of Diazepam Injection, USP in the United States”. 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 Announces the Approval of Diazepam Injection, USP in the United States Mumbai, India, Naples, Fla, JULY 31, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for its Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes. The U.S. FDA has approved Lupin’s Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes as bioequivalent to the reference listed drug (RLD) Valium® Injection 10 mg/2 mL (5 mg/mL) of Hoffman-LaRoche, Inc. and is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes had estimated annual sales of USD 77.9 million in the U.S. (IQVIA MAT May 2026). 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 VALIUM® is a registered trademark Atnahs Pharma US Limited Page 1 of 1