NSEPress Release28 Sept 2026 · 28 Sept 2026, 09:13 am

Press Release

Lupin Limited · LUPIN

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Lupin Limited has received tentative approval from the US FDA for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL via the 505(b)(2) pathway.

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Earnings Impact6/10
Growth Catalyst8/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment9/10

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Lupin Limited has informed the Exchange regarding a press release dated September 28, 2026, titled "Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension".

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September 28, 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 Novel Apixaban Oral Suspension”. 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 Novel Apixaban Oral Suspension Mumbai, India, Naples, FL, September 28, 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 New Drug Application for Apixaban Oral Suspension 1.25mg/mL via the 505(b)(2) pathway. Lupin's Apixaban Oral Suspension 1.25 mg/mL is an oral liquid formulation of apixaban, the active ingredient in Eliquis® (apixaban) of Bristol Myers Squibb, and provides an alternative administration option for adult patients requiring anticoagulation therapy Including those who may have difficulty swallowing tablets. “This tentative approval reflects our continued focus on developing differentiated medicines that address meaningful patient needs. Apixaban oral suspension expands the ways in which this important therapy could be administered, while reinforcing our commitment to building a differentiated portfolio,” said Vinita Gupta, CEO, Lupin. Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility, leveraging the company's U.S.-based manufacturing expertise to support high-quality standards, and supply reliability. 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 Press Release BSE: 500257 NSE: LUPIN REUTERS: LUPIN.BO BLOOMBERG: LPCIN Elise Titan Director – U.S. Communications, Lupin elisetitan@lupin.com *Safe Harbor Statement Eliquis is a registered trademark of Bristol-Myers Squibb Company