Latest news with #NorUrsodeoxycholicAcid
Business Upturn
3 days ago
- Health
- Business Upturn
Shilpa Medicare shares jump 3% after CDSCO approval for NorUDCA tablets
By Aman Shukla Published on August 11, 2025, 09:19 IST Shilpa Medicare Limited shares surged by 3% in morning trade following a major announcement from the company. As of 9:18 AM, the shares were trading 3.83% higher at Rs 863.85. The Central Drugs Standard Control Organization (CDSCO) has granted approval for Shilpa Medicare's Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg, indicated for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). This approval is a significant milestone as it marks the first global authorization of NorUDCA for NAFLD treatment. NAFLD is a widespread liver condition, affecting approximately 25% of the global population, which translates to nearly 1.2 billion people worldwide. In India alone, around 188 million people are estimated to suffer from NAFLD. If left untreated, NAFLD can advance to non-alcoholic steatohepatitis (NASH), causing severe liver damage and complications. NorUDCA is recognized for its choleretic and anti-inflammatory effects, which help improve bile flow, reduce liver inflammation, and potentially slow the progression of liver diseases related to NAFLD. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Standard
5 days ago
- Health
- Business Standard
Shilpa Medicare gets Shilpa Medicare approval for novel NAFLD drug NorUDCA
Shilpa Medicare has announced the receipt of approval of its, Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg, by the Central Drugs Standard Control Organization (CDSCO), marking a major milestone in innovative NAFLD therapy in India. The approval reinforces Shilpa Medicares commitment to addressing unmet medical needs in hepatology through innovation and evidence‐based solutions. This approval will allow Shilpa to become the first company in the World to launch this novel product in any part of the World for NAFLD. NorUDCA is the first‐in‐class treatment for non‐alcoholic fatty liver disease (NAFLD) in India, addressing a significant unmet medical need. NAFLD is currently the most prevalent liver condition globally, affecting about 25% of the worlds population (approximately 1.2 billion people) and impacting an estimated 188 million individuals in India alone. If not managed early, NAFLD may progress to non‐alcoholic steatohepatitis (NASH) and severe liver complications, underscoring the urgent necessity for effective therapy. These results collectively demonstrate a significant improvement in both liver structure and function, confirming NorUDCAs superior efficacy compared to placebo in NAFLD. Vishnukant Bhutada, managing director, Shilpa Medicare, said: "We are delighted to receive historic approval for NorUDCA, Indias first‐in‐class therapy for NAFLDmaking Shilpa the first company globally to obtain approval for NorUDCA in this indication. This milestone is a moment of immense pride for Shilpa and the nation, as we now pioneer the launch of its finished dosage form. This breakthrough exemplifies Shilpas unwavering dedication to innovation and accessible healthcare to millions battling liver disease in India and beyond. We are excited to introduce NorUDCA tabletsin India immediately, while advancing global regulatory efforts to bring this vital therapy to patients internationally. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company's consolidated net profit fell 40.77% to Rs 14.51 crore, while revenue from operations rose 13.40% to Rs 330.80 crore in Q4 FY25 over Q4 FY24. The scrip had advanced 1.46% to end at Rs 831.80 on the BSE on Friday.
Business Standard
5 days ago
- Health
- Business Standard
Shilpa Medicare receives CDSCO approval for NorUDCA Tablets
Used to treat Non?]alcoholic Fatty Liver Disease Shilpa Medicare announced the approval of its, Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg, by the Central Drugs Standard Control Organization (CDSCO), marking a major milestone in innovative Non Alcoholic Fatty Liver Disease (NAFLD) therapy in India. The approval reinforces Shilpa Medicarefs commitment to addressing unmet medical needs in hepatology through innovation and evidence]based solutions. This approval will allow Shilpa to become the first company in the World to launch this novel product in any part of the World for NAFLD. NorUDCA is the first]in]class treatment for Non]alcoholic Fatty Liver Disease (NAFLD) in India, addressing a significant unmet medical need.
Business Upturn
5 days ago
- Health
- Business Upturn
Shilpa Medicare gets CDSCO approval for NorUDCA tablets 500 mg, marks first global clearance for NAFLD treatment
By Aman Shukla Published on August 9, 2025, 10:52 IST Shilpa Medicare Limited has announced that it has received approval from the Central Drugs Standard Control Organization (CDSCO) for its Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). According to the company, this is the first approval for NorUDCA for NAFLD anywhere in the world. NAFLD is one of the most common liver conditions globally, affecting about 25% of the world's population, which is roughly 1.2 billion people. In India, the estimated patient population is around 188 million. If not addressed in time, NAFLD can progress to non-alcoholic steatohepatitis (NASH) and lead to serious liver complications. NorUDCA is described as having choleretic and anti-inflammatory properties, which can help improve bile flow, reduce inflammation in the liver, and potentially slow the progression of NAFLD and related liver disorders. Data from studies referenced by the company indicate that NorUDCA showed better results compared to placebo, with improvements in liver structure and function and no significant safety issues reported. The approval allows Shilpa Medicare to make NorUDCA available in India for NAFLD treatment. The company has stated that it aims to address an existing treatment gap for patients with this condition. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Associated Press
12-03-2025
- Health
- Associated Press
Shilpa Medicare Secures SEC-CDSCO Nod for Nor-Ursodeoxycholic Acid Tablets, Eyes Market Launch for NASH
RAICHUR, India , March 12, 2025 /PRNewswire/ -- Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED), a leading API and formulation manufacturer, announces that the Subject Expert Committee (SEC) of CDSCO has approved its Investigational New Drug (IND) – Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg – and recommended marketing authorization for treating non-alcoholic fatty liver disease (NAFLD). NAFLD, the most prevalent liver disease, affects approximately 25% of the global population (1.2 billion people), including 188 million in India. Left untreated, NAFLD can progress to non-alcoholic steatohepatitis (NASH), a severe and potentially fatal condition. Shilpa Medicare Ltd. had earlier completed phase-3 clinical studies of this novel product SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets - and presented the results of the trial titled, 'A phase - III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study', to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients suffering from Non-alcoholic Fatty Liver Disease to the SEC. The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. Key findings include: Liver Fibrosis Reversal: 83.3% of participants showed fibrosis reversal, with stabilization in the rest. ALT Normalization: Elevated alanine transaminase (ALT) levels, a key NAFLD marker, normalized in ~90% of participants within 12 weeks. These results position Nor UDCA as a breakthrough therapy for NAFLD, offering advantages over conventional UDCA, including enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and fibrosis reduction. Commenting on the development, Mr. Vishnukant Bhutada – Managing Director, Shilpa Medicare Limited, said, 'We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, 'Innovating for affordable healthcare', keeping in mind the unmet needs of a large patient pool. Based on the approval in India, we plan to reach out to Global regulatory authorities to seek scientific advice for introduction of this novel product internationally.' Founded in 1987, Shilpa Medicare offers APIs, Formulations, and Biologics, with facilities approved by major regulatory agencies. The company is also recognized for providing complete turnkey CDMO solutions for clients globally.
