NSEPress Release1 Jul 2026 · 1 Jul 2026, 04:44 pm
Press Release
Lupin Limited · LUPIN
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Lupin Limited has announced that the European Medicines Agency (EMA) has approved a change to the terms of marketing authorization for NaMuscla, a treatment for myotonia symptoms in non-dystrophic myotonic disorders, with new dosage strengths and expanded pediatric indication.
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Lupin Limited has informed the Exchange regarding a press release dated July 01, 2026, titled "Lupin Announces EMA Approval for NaMuscla® Expansion for Pediatric Indicationwith New Strengths".
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July 01, 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 EMA Approval for NaMuscla® Expansion for
Pediatric Indication with New Strengths”.
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 EMA Approval for NaMuscla® Expansion for Pediatric Indication
with New Strengths
NaMuscla is the only approved treatment for myotonia symptoms in NDM in Europe
Mumbai, Zug, July 1, 2026 – Global pharma major Lupin Limited (Lupin) today announced that the
European Medicines Agency (EMA) has approved a change to the terms of marketing authorization
for NaMuscla, supported by the Pediatric Investigation Plan (PIP). The approval includes two new
dosage strengths, 62 mg and 83 mg capsules, in addition to the existing 167 mg, and the revised
indications that cover symptomatic treatment of myotonia in children (6–11 years, weighing at least
20 kg), adolescents (12–17 years), and adults (≥18 years) with non-dystrophic myotonic disorders1.
Claus Jepsen, President, Global Specialty, Lupin, said, “This EMA approval for Pediatric Indication of
NaMuscla represents a significant step forward for patients and families living with non-dystrophic
myotonic disorders—especially children, where options are scarce. At Lupin, we remain committed
to broadening access to therapies that improve outcomes across every stage of care.”
Lupin is now working towards making new dosage strengths and expanded pediatric indication
available across Europe, subject to local implementation timelines and national reimbursement and
access processes.
Notes for Editors
About Myotonic Disorders and Non-Dystrophic Myotonias (NDM)
Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a
shared symptom called myotonia2. Myotonia can be described as an inability to relax a contraction of skeletal
muscle which originates from a voluntary muscular contraction such as shaking someone’s hand and blinking,
or everyday activities such as walking across a street and climbing stairs3, 4.
Non-dystrophic myotonias (NDM) are a sub-set of rare (prevalence of 1:100,0005), inherited, myotonic
disorders which are caused by mutations within ion channels in the sarcolemma membrane of skeletal
muscles. Non-dystrophic myotonias exhibit both sodium and chloride channelopathies which result in altered
membrane excitability6. For patients with NDM, myotonia is the most prominent symptom and demonstrates
different phenotypes in subgroups of NDM disorders, and can affect different parts of the body, such as legs,
arms, or facial muscles, more severely3.
Myotonia in NDM patients has an onset in childhood and persists across their lifetime7. Patients perceive that
myotonia increases in severity over time, impacting daily life3. Myotonia is described by patients in a variety
of ways (stiffness, cramps, pain, difficulty releasing a fist, or difficulty swallowing or eating) which can
contribute to substantial delays in diagnosis and treatment, leading to decreased patient quality-of-life and
often significant disability2-4.
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Press Release
BSE: 500257 NSE: LUPIN REUTERS: LUPIN.BO BLOOMBERG: LPCIN
About NaMuscla (mexiletine)
NaMuscla is the only antimyotonic agent licensed to treat symptomatic myotonia in children aged 6 to 11
years weighing at least 20 kg, adolescents aged 12 to 17 years and adult patients more than 18 years with
non-dystrophic myotonic disorders1. In randomized controlled trials, NaMuscla (167 to 500 mg/day) has been
shown to significantly reduce myotonia compared to placebo, reducing skeletal muscle hyperexcitability
through its use-dependent, voltage-gated, sodium channel blocking actions which are independent of the
cause of channel function. This resulted in an improvement in patient quality-of-life and other functional
outcomes, with gastro-intestinal discomfort reported as the most common adverse event, demonstrating
NaMuscla to be safe and well tolerated6-9.
References:
1. https://www.ema.europa.eu/en/medicines/human/EPAR/namuscla
2. Matthews E, et al. Brain 2010;133:9–22
3. Diaz-Manera J, et al. EMJ. 2021;6[2]:37-46
4. Trivedi JR, et al. Brain 2013; 136:2189-200
5. Emery AEH, Neuromuscular Discord 1991;1:19-29
6. Vicart S, et al. Neuromuscular Discord 2021; 31:1124-1135
7. Matthews E, et al. Pract Neurol 2021;0:1–10
8. Stunnenberg, et al. Muscle Nerve 2020;62(4):430-444
9. NaMuscla®. Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/namuscla-
epar-product-information_en.pdf
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
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