Lupin announced that the European Medicines Agency (EMA) has approved an expansion of the marketing authorization for NaMuscla to include pediatric indications. The approval, supported by a Pediatric Investigation Plan (PIP), introduces two new dosage strengths of 62 mg and 83 mg capsules, supplementing the existing 167 mg strength. This regulatory change allows for the symptomatic treatment of myotonia in children aged 6–11 years weighing at least 20 kg, adolescents aged 12–17 years, and adults aged 18 years and older with non-dystrophic myotonic disorders.

Key Approval Parameters

The EMA's decision broadens the scope of NaMuscla, which is the only approved treatment for myotonia symptoms in non-dystrophic myotonic disorders (NDM) in Europe. The following table outlines the specific details of the expanded authorization:

Strategic Significance

The addition of lower dosage strengths addresses the specific therapeutic needs of pediatric patients, who often require weight-adjusted dosing compared to adults. Claus Jepsen, President, Global Specialty at Lupin, highlighted that this approval represents a significant step forward for patients and families living with non-dystrophic myotonic disorders, particularly where options for children are scarce. The company is now working towards making these new dosage strengths available across Europe, subject to local implementation timelines and national reimbursement processes.

Disease Context

Non-dystrophic myotonias are rare, inherited neuromuscular disorders characterized by an inability to relax muscle contractions, impacting daily activities such as walking or grasping objects. With a prevalence of 1 in 100,000, these conditions often present in childhood and persist throughout a patient's lifetime. The expansion of NaMuscla's label aims to address the substantial delays in diagnosis and treatment often faced by this patient demographic.

Lupin has increased its indirect ownership in Multicare Pharmaceuticals Philippines to 99.89% through its wholly owned Netherlands subsidiary, Nanomi B.V. The stake consolidation, effective July 01, 2026, was achieved via a share acquisition and a concurrent buyback process, strengthening the Indian pharmaceutical major's control over its Southeast Asian operations.

Transaction Details

Nanomi completed the acquisition of 11,794,497 shares from existing shareholders of Multicare Pharmaceuticals Philippines (MPPI) on July 01, 2026. Simultaneously, MPPI finalized a buy-back of 61,118 shares from two existing shareholders on the same date. A separate buy-back process for the remaining 30,559 shares is currently in progress.

Shareholding Structure

Following these transactions, Nanomi's shareholding in MPPI rose significantly from 56.28% to 99.89%. The following table summarizes the key changes in the ownership structure:

The disclosure was submitted to the National Stock Exchange of India and BSE Limited under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.