Shilpa Medicare Launches NODUCA™ for MAFLD Treatment in India
Shilpa Medicare launches NODUCA™ in India, a novel therapy for MAFLD, following regulatory approval. Clinical trials showed significant efficacy and safety. The company aims for global expansion.
The launch of a new drug for a prevalent liver disorder is likely to have a medium impact on the company's business and market position.
The announcement highlights the launch of a new drug with positive clinical trial results and management commentary, indicating a positive outlook for the company.
* Shilpa Medicare has launched NODUCA™ (norursodeoxycholic acid) in India for the first time, a therapy for metabolic dysfunction-associated fatty liver disease (MAFLD). * This follows approval from the Central Drugs Standard Control Organisation (CDSCO) in August 2025. * NorUDCA offers anti-inflammatory action, anti-fibrotic effect, and choleretic protection. * Clinical trials in India showed efficacy at 1500 mg daily with no serious adverse events; 83.3% of patients showed fibrosis reversal and 90% achieved normal liver enzyme levels within 3 months. * MAFLD affects an estimated 188 million patients in India. * Shilpa Medicare is commencing commercial launch in India under its own brand NODUCA™ and has partnered with 3 partners for India market on their own brand. * The company will pursue international regulatory approvals to expand access globally. * Mr. Vishnukant Bhutada, Managing Director, commented: “I am delighted to announce the launch of NorUDCA in the Indian market which is a culmination of our dedication to innovation. We are proud to be the first to bring this therapy to patients, and with our multi -pronged commercial strategy, we are confident in making a meaningful impact on the fight against MAFLD”
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Shilpa Medicare Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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See the model portfoliosA plain-language summary of a public exchange filing by Shilpa Medicare Limited. Read the original for the full detail.