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Lupin Ltd — Regulatory Filings 2026
May 5, 2026
61031_rns_2026-05-05_5fc34e20-3408-4402-ad80-321a98a27a13.pdf
Regulatory Filings
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LUPIN
May 05, 2026
National Stock Exchange of India Limited
Exchange Plaza,
Bandra Kurla Complex,
Bandra (East),
Mumbai - 400 051
Symbol: LUPIN
BSE Limited
P. J. Towers, Dalal Street,
Mumbai Samachar Marg,
Mumbai - 400 001
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 Glycerol Phenylbutyrate Oral Liquid".
The same is for your information and dissemination.
Thanking you,
For LUPIN LIMITED
AMIT KUMAR GUPTA
EMILIN, Hypothet, NDP 504045 GUPTA
Tel: +91-21-82850204
E-mail: ETHZ075350470350404000000000000000000000000000000000000000000000000000000000000000000000000000000
www.lupin.com
www.lupin.com
www.lupin.com
www.lupin.com
www.lupin.com
www.lupin.com
www.lupin.com
www.lupin.com
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
[email protected] | www.lupin.com
Press Release
LUPIN
BSE: 500257
NSE: LUPIN
REUTERS: LUPIN.BO
BLOOMBERG: LPCIN
Lupin Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid
Mumbai, India, Naples, Fla, May 5, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.
Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, is bioequivalent to the reference listed drug (RLD), Ravicti® Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC. It is indicated for chronic management of patients with urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
The product sales for Glycerol Phenylbutyrate Oral Liquid (RLD Ravicti®) were USD 337 million for the year ended December 2025. (IQVIA MAT DEC 2025)
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
[email protected]
Elise Titan
Director – U.S. Communications, Lupin
[email protected]
*Safe Harbor Statement
Ravicti® is the registered trademark of Horizon Therapeutics U.S. Holding LLC, a subsidiary of Amgen Inc.
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