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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Full Announcement
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
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