Latest news with #ShilpaMedicare
Business Standard
4 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
4 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.
The Wire
04-08-2025
- Business
- The Wire
Alveolus Bio Secures Strategic Investment from Shilpa Medicare to Advance Groundbreaking Pulmonary Therapeutics
Shilpa Medicare Serves as Lead Investor, Positioning Alveolus Bio for Phase 2 Clinical Trials and First-in-Human Studies CAMBRIDGE, Mass. and BIRMINGHAM, Ala. and RAICHUR, India, Aug. 4, 2025 /PRNewswire/ -- Alveolus Bio, a pioneering respiratory drug development biotech company founded by Dr. Vivek Lal from University of Alabama at Birmingham, AL, has announced a strategic financing round led by Shilpa Medicare Limited (BSE: 524742) (NSE: SHILPAMED), a prominent global pharmaceutical company with extensive expertise in respiratory therapeutics manufacturing and biotechnology innovation. Through this collaboration, Shilpa Biologics, the biologics arm of Shilpa Medicare, will become Alveolus Bio's exclusive global development and manufacturing partner. This partnership propels Alveolus Bio's live biotherapeutics and small molecule platform towards Phase 2 and first-in-human clinical trials, with a lead asset for COPD progressing rapidly. Shilpa Medicare brings deep experience in drug discovery, development, and manufacturing, along with strong regulatory capabilities. Their investment and strategic involvement will accelerate the clinical advancement of Alveolus Bio's resMIT (respiratory microbiota-based inhaled therapeutics) platform. This novel platform enables targeted delivery of inhaled therapies to deep lung regions, addressing unmet needs in diseases such as COPD, Bronchopulmonary Dysplasia (BPD), and Pulmonary Fibrosis. "Securing Shilpa as our lead investor is a transformative step," said Gaurav Mehta, CEO of Alveolus Bio. "Their global pharmaceutical leadership aligns perfectly with our vision to redefine how lung diseases are treated." "Alveolus Bio's breakthrough science is poised to transform respiratory care. Through this strategic partnership with Shilpa, we combine disruptive biotech innovation with world-class commercialization, bringing life-changing therapies faster to the market," said Dr. C. Vivek Lal, Founder and CSO, Alveolus Bio. "Shilpa has always focused on enabling breakthrough biologics," said Vishnukant Bhutada, Managing Director, Shilpa Medicare. "This partnership strengthens our innovation pipeline and reinforces our role as a trusted global partner for biotech development." The financing round remains open to other strategic investors who share Alveolus Bio's vision of transforming respiratory medicine. About Shilpa Medicare Shilpa Medicare is a global pharmaceutical company with capabilities across drug discovery to commercialization, specializing in respiratory therapeutics and biotech innovation. Visit About Alveolus Bio A Biostack Ventures company, Alveolus Bio is developing first-in-class therapies for lung diseases using its proprietary resMIT platform. Its pipeline includes programs for COPD, BPD, Pulmonary Fibrosis, Cystic Fibrosis, and more. This is an auto-published feed from PTI with no editorial input from The Wire.
Yahoo
04-08-2025
- Business
- Yahoo
Alveolus Bio Secures Strategic Investment from Shilpa Medicare to Advance Groundbreaking Pulmonary Therapeutics
Shilpa Medicare Serves as Lead Investor, Positioning Alveolus Bio for Phase 2 Clinical Trials and First-in-Human Studies CAMBRIDGE, Mass. and BIRMINGHAM, Ala. and RAICHUR, India, Aug. 4, 2025 /PRNewswire/ -- Alveolus Bio, a pioneering respiratory drug development biotech company founded by Dr. Vivek Lal from University of Alabama at Birmingham, AL, has announced a strategic financing round led by Shilpa Medicare Limited (BSE: 524742) (NSE: SHILPAMED), a prominent global pharmaceutical company with extensive expertise in respiratory therapeutics manufacturing and biotechnology innovation. Through this collaboration, Shilpa Biologics, the biologics arm of Shilpa Medicare, will become Alveolus Bio's exclusive global development and manufacturing partner. This partnership propels Alveolus Bio's live biotherapeutics and small molecule platform towards Phase 2 and first-in-human clinical trials, with a lead asset for COPD progressing rapidly. Shilpa Medicare brings deep experience in drug discovery, development, and manufacturing, along with strong regulatory capabilities. Their investment and strategic involvement will accelerate the clinical advancement of Alveolus Bio's resMIT (respiratory microbiota-based inhaled therapeutics) platform. This novel platform enables targeted delivery of inhaled therapies to deep lung regions, addressing unmet needs in diseases such as COPD, Bronchopulmonary Dysplasia (BPD), and Pulmonary Fibrosis. "Securing Shilpa as our lead investor is a transformative step," said Gaurav Mehta, CEO of Alveolus Bio. "Their global pharmaceutical leadership aligns perfectly with our vision to redefine how lung diseases are treated." "Alveolus Bio's breakthrough science is poised to transform respiratory care. Through this strategic partnership with Shilpa, we combine disruptive biotech innovation with world-class commercialization, bringing life-changing therapies faster to the market," said Dr. C. Vivek Lal, Founder and CSO, Alveolus Bio. "Shilpa has always focused on enabling breakthrough biologics," said Vishnukant Bhutada, Managing Director, Shilpa Medicare. "This partnership strengthens our innovation pipeline and reinforces our role as a trusted global partner for biotech development." The financing round remains open to other strategic investors who share Alveolus Bio's vision of transforming respiratory medicine. About Shilpa MedicareShilpa Medicare is a global pharmaceutical company with capabilities across drug discovery to commercialization, specializing in respiratory therapeutics and biotech innovation. Visit About Alveolus BioA Biostack Ventures company, Alveolus Bio is developing first-in-class therapies for lung diseases using its proprietary resMIT platform. Its pipeline includes programs for COPD, BPD, Pulmonary Fibrosis, Cystic Fibrosis, and more. View original content: SOURCE Shilpa Medicare Limited Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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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.
