Latest news with #ShilpaMedicareLimited
Business Upturn
11-08-2025
- 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 Upturn
09-08-2025
- 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
&w=3840&q=100)
Business Standard
16-07-2025
- Business
- Business Standard
Why did Shilpa Medicare share jump 5% in trade today? top details here
Shilpa Medicare share price: Pharmaceutical company Shilpa Medicare share price was in demand on Wednesday, July 16, 2025, with the scrip rising up to 4.99 per cent to hit an intraday high of ₹939.10 per share. Around 1:30 PM, Shilpa Medicare share price was trading 4.93 per cent higher at ₹938.50. By comparison, BSE Sensex was trading 0.08 per cent lower at 82,640.01 levels. CATCH STOCK MARKET LIVE UPDATES TODAY Why did Shilpa Medicare share price rise in trade today? Shilpa Medicare share price gained in trade after the company announced a positive regulatory update from the US health regulator, United States Food and Drug Administration (USFDA). The pharma firm said its Unit VI at Dabaspet, Bengaluru received an Establishment Inspection Report (EIR) with a 'Voluntary Action Indicated' (VAI) classification from the USFDA. The EIR followed a Good Manufacturing Practices (GMP) inspection conducted between October 24-30, 2024. In an exchange filing, Shilpa Medicare said, 'This is to inform you that Shilpa Medicare Limited, Unit VI, Dabaspet, Bengaluru, Karnataka, India has received EIR with VAI (Voluntary Action Indicated) classification, from USFDA, for the GMP inspection which was conducted from October 24 – 30, 2024.' The unit is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms including Oral Dissolving Films and Transdermal Systems. Meanwhile, the unit already holds approvals from key global regulators, including EMA (Europe), MHRA (UK), SFDA (Saudi Arabia), and TGA (Australia). It currently supplies oral film products to the US and other markets, while filings for transdermal products have been made in Europe. Shilpa Medicare Q4 results Shilpa Medicare reported a mixed set of numbers in Q4FY25. While revenue from operations grew 13.3 per cent year-on-year (Y-o-Y) to ₹330.80 crore and earnings before interest, tax, depreciation and amortisation (Ebitda) rose 15 per cent to ₹84 crore, net profit (PAT) declined 40.8 per cent to ₹14.51 crore. About Shilpa Medicare Shilpa Medicare Limited is a global pharmaceutical company with a strong presence in regulated markets such as the USA, Europe, and Japan. The company specialises in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and finished dosage formulations, with a particular focus on oncology. Its product range includes tablets, capsules, injectables, and transdermal patches, all manufactured to meet international quality standards. Additionally, Shilpa Medicare provides end-to-end Contract Development and Manufacturing Organisation (CDMO) services, catering to a wide spectrum of pharmaceutical needs. Beyond its core offerings, the company is actively investing in research and development, focusing on novel drug delivery systems and expanding into emerging therapy areas, including biotech products. The market capitalisation of Shilpa Medicare is ₹9,177.68 crore, according to BSE. The company falls under the BSE SmallCap category.
Business Upturn
04-07-2025
- Business
- Business Upturn
Shilpa Medicare subsidiary clears GMP inspection from ANVISA with no major observations
By Aman Shukla Published on July 4, 2025, 16:10 IST Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Pharma Lifesciences Limited (Unit-1), has successfully completed a Good Manufacturing Practice (GMP) inspection conducted by the Brazilian regulatory authority, ANVISA. In the exchange filing, the company shared, 'This is to inform you that the Shilpa Medicare Limited's 100% subsidiary, Shilpa Pharma Lifesciences Limited, Unit-1 has successfully completed GMP inspection from Brazilian regulatory authority, ANVISA. ' The inspection took place from June 30 to July 4, 2025, and concluded with no critical or major observations—a key milestone for the company's global regulatory compliance. Only minor procedural observations and recommendations were noted, which were discussed during the course of the audit. Shilpa Medicare stated that it remains committed to maintaining the highest quality and regulatory standards. The company will submit a Corrective and Preventive Action (CAPA) plan to address the minor points raised, within the stipulated timelines set by the agency. This successful outcome reinforces Shilpa's position in regulated markets and supports its ongoing efforts to expand its international presence, particularly in Latin America. 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 Upturn
23-05-2025
- Business
- Business Upturn
Shilpa Medicare subsidiary partners with Orion Corporation to commercialize Recombinant Human Albumin in Europe
By Aman Shukla Published on May 23, 2025, 15:05 IST Shilpa Medicare Limited has announced that its wholly owned subsidiary, Shilpa Biocare Private Limited, has entered into a strategic agreement with Orion Corporation, a pharmaceutical company based in Finland. The agreement grants Orion exclusive rights to distribute, market, and sell Shilpa's Recombinant Human Albumin in the European market. The product, currently under development, is a biosimilar version of human albumin produced using a non-human expression system. This production approach aims to offer an alternative to plasma-derived albumin by eliminating risks related to human pathogens and improving scalability. As part of the agreement, Shilpa Biocare is eligible to receive development and regulatory milestone payments from Orion. Shilpa has been investing in the development of Recombinant Human Albumin for approximately eight years and has established a large-scale fermentation facility to support its production. Recombinant Human Albumin is used in a variety of therapeutic applications and plays a critical role in the manufacturing of vaccines and other biologics. The collaboration is expected to leverage Orion's experience in the European pharmaceutical market, including its regulatory and distribution capabilities. The partnership reflects ongoing industry efforts to enhance the availability of biologics and biosimilars that meet safety and quality standards. 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
