Latest news with #VishnukantBhutada
Business Standard
27-05-2025
- Business
- Business Standard
Shilpa Medicare slides after Q4 PAT drop 41% YoY to Rs 15-cr
Shilpa Medicare declined 1.25% to Rs 878.35 after 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. Profit before exceptional items and tax stood at Rs 43.35 crore in Q4 FY25, up 100.88% from Rs 21.58 crore posted in the corresponding quarter previous year. The firm reported exceptional items of Rs 28.08 crore during the quarter. EBITDA jumped 15% to Rs 84 crore in Q4 FY25 from Rs 73 crore in Q4 FY24. EBITDA margin remained constant at 25% in Q4 FY25 compared to Q4 FY24. Total expenses were up by 9.12% year on year to Rs 297.32 crore in the quarter ended 31 March 2025. The cost of materials consumed stood at Rs 85.14 crore (down 15.83% YoY), while employee benefits expense was at Rs 70.93 crore (up 6.72% YoY). On a full-year basis, the company's consolidated net profit surged 145.65% to Rs 78.29 crore on an 11.70% jump in revenue from operations to Rs 1,286.41 crore in FY25 over FY24. Vishnukant Bhutada, managing director of Shilpa Medicare, said, FY25 performance reflects our pursuit of a differentiated business model enabling us to grow with improved profitability. In FY25, Shilpa Medicare has emerged stronger, turning years of strategic investments and relentless perseverance into remarkable achievements in differentiated initiatives like the launch of two NDAs in US market, filing of transdermal patch product in EU, SEC clearance of Nor-UDCA in India and OLC filing by our partner with US FDA. Our unwavering commitment to innovation and R&D has borne fruit, with a significant breakthrough in out-licensing our flagship productrecombinant human albuminfor commercialization across EU region in strategic partnership with Orion Corporation. Besides this, we also saw a very successful year on the regulatory front, as we received EIR for our API Unit 1, along with EU GMP certifications for our FDF Unit 6 (having ODF & TDP manufacturing capabilities) and for our Biologics unit. I believe this will help in enabling us to further scale up our biologics CDMO platform and give us the opportunity to monetize our biosimilar pipeline for large regulated markets. With asset utilization improvement across key verticals, we remain confident of delivering improved profitability in FY26. As we advance, we remain committed to leveraging our R&D strengths, regulatory compliance, and operational agility to create long-term value. Meanwhile, the companys board has decided to pay a dividend of Rs 1 per equity share for FY 2024-2025. The final dividend, if approved by the members at the ensuing Annual General Meeting, shall be paid within the statutory timelines prescribed under applicable laws. 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.
Yahoo
01-04-2025
- Business
- Yahoo
Amneal Launches BORUZU™, First Ready-to-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma
- First ready-to-use, subcutaneous formulation of Bortezomib now available - Marks Amneal's fourth 505(b)(2) injectable product launch in the last year BRIDGEWATER, N.J., April 01, 2025--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and Shilpa Medicare Limited ("Shilpa") today announced the U.S. launch of BORUZU™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration. BORUZU™ (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade®, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU has a unique J-code. "As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the U.S. launch of BORUZU™ in our oncology portfolio. This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement. Our commitment remains steadfast in delivering differentiated oncology products that enhance patient care and access," said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology. "This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance and have the potential to reduce patient wait times. This development exemplifies Shilpa's constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool," said Vishnukant Bhutada, Managing Director of Shilpa Medicare. The most commonly reported adverse reactions for BORUZU™ in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. For full prescribing information, see package insert located here. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit and follow us on LinkedIn. About Shilpa Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including novel injectables, orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its strong R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities. For more information, please visit Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as "plans," "expects," "will," "anticipates," "estimates," and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, "Risk Factors" in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. View source version on Contacts Investor Contact Anthony DiMeoVP, Investor Shilpa Contact Monish ShahHead Strategic & Investor Sign in to access your portfolio
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
