Highlights

• Shilpa Medicare has launched NODUCA™, the first NorUDCA-based therapy introduced anywhere in the world for MAFLD.
• Clinical studies in India recorded high efficacy for NorUDCA at a 1500 mg daily dose with no serious adverse events.
• The company has initiated a commercial rollout and partnered with three additional players to expand availability in the Indian market.

Shilpa Medicare Limited (NSE:SHILPAMED) has announced the commercial launch of NODUCA™, a Nor Ursodeoxycholic Acid (NorUDCA) formulation, marking the first availability of this therapy in India and globally. The product follows approval from the Central Drugs Standard Control Organisation (CDSCO) in August 2025 and is intended for the treatment of metabolic dysfunction-associated fatty liver disease (MAFLD), a condition that affects millions across India.

First Global Launch of NorUDCA-Based Treatment

Shilpa Medicare Limited has formally introduced NODUCA™, the first NorUDCA therapy made available in India or internationally for the treatment of metabolic dysfunction-associated fatty liver disease (MAFLD). The launch comes after CDSCO granted approval in August 2025, making this a notable milestone in the pharmaceutical landscape. MAFLD, earlier known as NAFLD, is recognised as the most widespread liver disorder globally and affects a significant proportion of the Indian population.

NODUCA™ has been developed to address metabolic dysfunction-related liver conditions through a distinctive bile acid approach that differs from existing treatment options. The therapy is intended for patients experiencing inflammation, liver scarring and cholestatic complications associated with MAFLD.

Therapeutic Role and Clinical Outcomes

NorUDCA has demonstrated three primary therapeutic effects in MAFLD patients. It is designed to reduce inflammation in hepatic and ductular tissues, support the reversal of fibrosis, and aid toxin removal through enhanced bile secretion. Phase 3 clinical data from studies conducted across India showed notable outcomes, with a high proportion of patients exhibiting fibrosis reversal and improved liver enzyme levels within a three-month period.

According to the company, the therapy was tested at a dose of 1500 mg per day and showed favourable tolerability. No serious adverse events were reported, indicating suitability for long-term administration. The results support the broader potential of NorUDCA for patients for whom treatment choices have historically been limited.

Commercial Rollout and Market Introduction

Following regulatory clearance, Shilpa Medicare has commenced the market launch of NODUCA™ under its own brand. Additionally, the company has partnered with three firms that will introduce the therapy under their respective brands in India. This multi-channel approach is expected to widen the product’s reach within the domestic market.

The company has also outlined plans to seek approvals in international jurisdictions with the objective of expanding access to the therapy for patients worldwide. By introducing NorUDCA to the market, Shilpa Medicare aims to enhance treatment availability for MAFLD, a condition estimated to affect more than 180 million individuals in India.

Company Profile

Shilpa Medicare Limited, listed on both BSE and NSE, operates across active pharmaceutical ingredients, formulations and biologics with a focus on oncology, infectious diseases and specialty medicines.