NSEPress Release8 Oct 2026 · 8 Oct 2026, 09:00 pm
Press Release
Lupin Limited · LUPIN
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Lupin Limited has received US FDA approval for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe, with estimated annual sales of USD 52.3 million in the US.
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Governance Concern1/10
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Balance Sheet Risk1/10
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Market Sentiment9/10
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Lupin Limited has informed the Exchange regarding a press release dated October 08, 2026, titled "Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion, USP".
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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
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