NSEPress Release1d ago · 4 Sept 2026, 05:38 pm
Press Release
Lupin Limited · LUPIN
✦ AI Summary▲ PositiveOrder Win
Lupin Limited has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg, with estimated annual sales of USD 70.7 million in the U.S.
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Lupin Limited has informed the Exchange regarding a press release dated September 04, 2026, titled "Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP".
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September 04, 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 Modafinil Tablets, 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 Modafinil Tablets, USP
Mumbai, India, Naples, Fla, September 4, 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 Modafinil Tablets USP, 100 mg and 200 mg.
The U.S. FDA has approved Lupin’s Modafinil Tablets USP, 100 mg and 200 mg as bioequivalent to
the reference listed drug (RLD), Provigil® Tablets of Nuvo Pharmaceuticals (Ireland) DAC, and is
indicated to improve wakefulness in adult patients with excessive sleepiness associated with
narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD).
Modafinil Tablets (RLD Provigil®) had estimated annual sales of USD 70.7 million in the U.S. (IQVIA
MAT Jul 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
Provigil is the registered trademark of Nuvo Pharmaceuticals (Ireland) DAC
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