Latest news with #ShilpaMedicareLimited
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Business Standard
4 days ago
- 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
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.
