BSECompany Update3d ago · 17 Aug 2026, 12:21 pm
Lupin Announces Approval from U.S. FDA for Pitolisant Tablets.
Lupin Ltd · 500257
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Lupin Ltd has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix for the indications in the approved labeling.
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Earnings Impact8/10
Growth Catalyst6/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10
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Full Announcement
Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
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August 17, 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 Approval from U.S. FDA for Pitolisant Tablets”.
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 Approval from U.S. FDA for Pitolisant Tablets
Mumbai, Naples, August 17, 2026: Global pharma major Lupin Limited (Lupin) today announced that
it has received the final approval from the United States Food and Drug Administration (U.S. FDA) for
its Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mg.
The U.S. FDA has approved Lupin’s Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix®
for the indications in the approved labeling.
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 6 research
centers globally, along with a dedicated workforce of over 26,000 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
https://www.lupin.com/safeharborstatement/
Wakix® is a registered trademark of Bioprojet Europe, Ltd.
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