Shilpa Medicare Launches NODUCATM for MAFLD Treatment in India
Filing Summary
Shilpa Medicare Limited has launched NODUCATM, a novel bile acid therapy, in India to treat metabolic dysfunction-associated fatty liver disease (MAFLD). This marks the first global introduction of Nor Ursodeoxycholic Acid (NorUDCA) following approval by the Central Drugs Standard Control Organisation in August 2025. The therapy offers anti-inflammatory, anti-fibrotic, and choleretic benefits, with clinical trials showing significant efficacy and safety. Shilpa Medicare is the first company to market this treatment for MAFLD, impacting an estimated 188 million patients in India. The company plans further international regulatory approvals.
Shilpa Medicare Limited has announced the launch of NODUCATM, a novel bile acid therapy, in India for the treatment of metabolic dysfunction-associated fatty liver disease (MAFLD). This introduction follows the approval granted by the Central Drugs Standard Control Organisation (CDSCO) in August 2025. NODUCATM, containing Nor Ursodeoxycholic Acid (NorUDCA), is designed to address liver health by reducing inflammation, fibrosis, and cholestasis through mechanisms distinct from conventional therapies.
The filing does not specify financial terms or commercial arrangements related to the launch of NODUCATM. However, it highlights that Shilpa Medicare has partnered with three entities for the Indian market, indicating a collaborative approach to distribution and commercialization within the country.
The scope of the launch includes the introduction of a first-in-class therapy for MAFLD, previously known as non-alcoholic fatty liver disease (NAFLD). NorUDCA provides three therapeutic benefits: anti-inflammatory action, anti-fibrotic effect, and choleretic protection. Clinical trials in India demonstrated efficacy at a dose of 1500 mg daily, with no serious adverse events reported. The therapy is suitable for long-term use, offering a new treatment option for patients with limited alternatives.
MAFLD is the most prevalent liver disorder globally, affecting approximately one in four individuals. In India, an estimated 188 million patients are impacted. The launch of NODUCATM positions Shilpa Medicare as the first company to bring Nor Ursodeoxycholic tablets to market for this condition. The company emphasizes its commitment to innovation and addressing unmet medical needs through evidence-based healthcare solutions.
The commercial launch of NODUCATM in India is underway, with Shilpa Medicare pursuing further international regulatory approvals to expand access to this therapy globally. The company aims to enhance liver health treatment options for patients worldwide.
Shilpa Medicare Limited is a leading Indian pharmaceutical company focused on developing, manufacturing, and marketing APIs, formulations, and biologics across oncology, infectious diseases, and specialty segments. The company has expertise in complex generics, novel drug delivery systems, and CDMO services, serving patients in over 80 countries.