BSECompany Update8 Oct 2026 · 8 Oct 2026, 08:58 pm

Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion, USP

Lupin Ltd · 500257

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Lupin Ltd has received US FDA approval for its Phytonadione Injectable Emulsion USP, a generic version of a product with estimated annual sales of USD 52.3 million in the US.

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

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

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October 08, 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 Phytonadione Injectable Emulsion, 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 Phytonadione Injectable Emulsion, USP Mumbai, India, Naples, Fla, October 08, 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 Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe. The U.S. FDA has approved Lupin’s Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited and is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency. Phytonadione Injectable Emulsion had estimated annual sales of USD 52.3 million in the U.S. (IQVIA MAT Aug 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 Page 1 of 1