Latest news with #ShilpaMedicareLimited
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
Business Upturn
06-05-2025
- Business
- Business Upturn
Shilpa Medicare's Bengaluru facility secures GMP approval from EMA for Oral Mouth Dissolving Films and Transdermal Systems
By Aman Shukla Published on May 6, 2025, 12:01 IST Shilpa Medicare Limited, a leading pharmaceutical company, has announced that its Unit VI facility in Dabaspet, Bengaluru, Karnataka has received Good Manufacturing Practice (GMP) approval from the European Medicines Agency (EMA). This milestone follows a successful inspection carried out by the Finnish Medicines Agency on behalf of EMA between March 10–14, 2025, which concluded with only minor observations. The EMA GMP certification covers key operations at the facility, including the manufacturing, packaging, testing, storage, and distribution of two advanced pharmaceutical dosage forms: Oral Mouth Dissolving Films (ODFs) and Transdermal Systems. This achievement marks a significant step forward for Shilpa Medicare, as both Oral Films and Transdermal Patches are complex, niche drug delivery systems. These dosage forms offer distinct advantages over traditional oral medications, such as enhanced patient convenience, improved dosing compliance, and efficient drug delivery — whether rapid or sustained — for local or systemic therapeutic needs. Shilpa Medicare's Unit VI is already accredited by other major international regulatory agencies, including the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Australia's Therapeutic Goods Administration (TGA). The facility is currently supplying Oral Film products to the US and other international markets, highlighting its global compliance and capabilities. With this EMA approval, Shilpa Medicare is now well-positioned to expand its presence across the European Union, bringing its innovative range of Oral Film and Transdermal Patch products to a broader patient population. The company also has a robust product pipeline in these dosage forms, which includes approved products, pending approvals, and candidates in advanced stages of development. 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.
Yahoo
12-03-2025
- Health
- Yahoo
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. For inquiries : info@ View original content: SOURCE Shilpa Medicare Limited Sign in to access your portfolio
