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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
5 hours ago
- Yahoo
DKSH Brunei Strengthens Healthcare Supply Chain with Warehouse Expansion
DKSH has officially launched its newly expanded distribution center in Brunei, strengthening its capabilities to support the growth and resilience of the nation's healthcare supply chain. BANDAR SERI BEGAWAN, Brunei, June 12, 2025 /PRNewswire/ -- DKSH Brunei, a leading provider of Market Expansion Services in Asia and beyond, has officially inaugurated its newly extended warehouse facility in Brunei. The expansion adds an additional 4,000 square feet of storage capacity, reinforcing DKSH Brunei's commitment to advancing the nation's healthcare logistics infrastructure. The enhanced facility is designed to improve operational efficiency, regulatory compliance, and temperature-controlled storage, ensuring the safe and timely delivery of healthcare products nationwide. Among other things, the facility now features advanced compliance systems, improved operational workflows, and enhanced quality assurance protocols. During the launch event, Sandeep Tewari, Vice President, Healthcare, Malaysia & Brunei, DKSH, shared: "This warehouse extension marks a significant step forward following our acquisition of MediPharm Sdn. Bhd. last year. This investment reaffirms our long-term commitment to Brunei by enabling us to meet growing demand, better support our clients, and remain a trusted partner across the value chain – while enhancing our capacity to deliver high-quality healthcare solutions and create meaningful impact for the market and the communities we serve, in line with our purpose of enriching people's lives." In his address, Mr. Joel Solomon, Head, Supply Chain Management, Malaysia & Brunei, DKSH, emphasized: "This warehouse extension is not just an expansion of physical space – it is a reflection of our strategic focus on resilience, agility, and long-term partnership. Our focus remains on delivering life-saving products efficiently and reliably in Brunei, and this facility is a key step in that direction." The event welcomed esteemed guests including government officials, healthcare stakeholders, and DKSH's strategic partners. Attendees toured the upgraded warehouse. With over a decade of experience in Brunei, DKSH continues to be a trusted logistics partner in the healthcare industry, delivering compliant, reliable, and efficient supply chain solutions that help ensure access to essential medical products across the nation. About DKSH For 160 years, DKSH has been delivering growth for companies in Asia and beyond its Business Units Healthcare, Consumer Goods, Performance Materials, and Technology. As a leading Market Expansion Services provider, DKSH offers sourcing, market insights, marketing and sales, eCommerce, distribution and logistics as well as after-sales services, following its purpose of enriching people's lives. DKSH is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. Listed on the SIX Swiss Exchange, DKSH operates in 36 markets with 28,060 specialists, generating net sales of CHF 11.1 billion in 2024. DKSH Business Unit Healthcare distributes pharmaceuticals, consumer health, over-the-counter products and medical devices. With around 7,940 specialists, the Business Unit generated net sales of CHF 5.7 billion in 2024. View original content to download multimedia: SOURCE DKSH Malaysia Sdn. Bhd. 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
Yahoo
6 hours ago
- Yahoo
Philips Future Health Index 2025: Delayed care and lost clinical time call for accelerated AI adoption in APAC
66% of patients surveyed in APAC are experiencing delays in seeing specialist doctor, with an average waiting time of 47 days 89% of healthcare professionals believe that AI and predictive analytics can save lives by facilitating earlier interventions Building trust among patients and healthcare professionals around AI key to driving wider adoption SINGAPORE, June 12, 2025 /PRNewswire/ -- Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today released the Asia Pacific (APAC) findings from its 10th annual Future Health Index (FHI) report, the largest global healthcare survey of its kind. The report draws insights on key concerns from healthcare professionals and patients in 16 countries, including Australia, Indonesia, and South Korea. Findings show that despite strong optimism about artificial intelligence's (AI) potential to ease pressure on APAC's healthcare systems, trust and implementation concerns persist. "The need for AI has never been greater. Our survey shows that patients are anxiously waiting more than a month for specialist care, while some healthcare professionals are losing about four working weeks of clinical time a year due to incomplete patient data," said Jasper Westerink, Senior Vice President and Representative Director of Philips Japan and Acting Managing Director of Philips APAC. "There is a clear role for AI to help clinicians act faster, make better decisions, and anticipate patient needs earlier as we strive to deliver better care for more people." Worsening patient outcomes because of care delays call for accelerated AI adoption About two in three patients (66%) surveyed in APAC are waiting nearly one and a half months to see a specialist doctor, with an average waiting time of 47 days. Generally, one in three patients (33%) in APAC report that their health has deteriorated due to delays in seeing a doctor, with one in four (25%) ultimately going to the hospital as a result of long waiting times. AI has the potential to transform care delivery and significantly improve patient outcomes across APAC. 81% of healthcare professionals in APAC believe that digital health technologies, including AI and predictive analytics, will lead to a reduction in hospital admissions in the future. 86% of healthcare professionals anticipate that these technologies will decrease the need for acute or emergency medical procedures and interventions. 89% of healthcare professionals believe that AI and predictive analytics can save lives by facilitating earlier interventions. Workforce challenge and data burdens call for AI relief Three in four healthcare professionals (76%) in APAC report losing valuable clinical time due to incomplete or inaccessible patient data, with close to one-third (31%) of these losing over 45 minutes per shift, adding up to 23 full days a year lost by each professional. Similarly, two in five (39%) clinicians say they are now spending less time with patients and more time on administrative tasks than they were five years ago. These exacerbate the workforce challenge experienced by healthcare professionals in APAC, as estimated by the World Health Organization. The shortage of health workers in Southeast Asia alone will be 6.9 million respectively in 2030, nearly 40% of the global shortage burden.[1] About 300 healthcare professionals surveyed shared the following concerns if AI is not implemented: 45% worry about an expanding patient backlog 42% cite growing burnout from non-clinical tasks 40% worry about their inability to provide cutting-edge care Addressing AI concerns from HCPs and patients crucial for widespread adoption A majority of healthcare professionals (81%) in APAC are involved in developing new technology at their organizations. However, 39% believe that the new technologies developed are not catered to their needs. Concerns around accountability persist, with 71% sharing concerns about the legal liability for AI usage, while 66% worry that potential data biases in AI applications could widen disparities in health outcomes. Among patients, a majority (75%) welcome the increased use of technology if it improves access to care and benefits them. Around half are concerned that it could reduce face-to-face time with their doctors (51%) and are worried about data security when new technologies are introduced in healthcare (54%). Trust key to transforming healthcare in APAC For the majority of healthcare professionals surveyed (84%) building trust in AI has to involve support with guidelines, issues and liability. In addition, healthcare professionals cite the development of evidence-based, transparent, and monitored AI solutions (72%), followed by reassurance on data security issues, with 51% of healthcare professionals seeking clarity in this area. For patients, about three in four (74%) welcome the use of more technology in healthcare if it helps make it easier to see a healthcare professional and if it helps improve care for patients like themselves (75%). Healthcare professionals play a key role in building trust between patients and AI. Majority of patients (86%) would feel more comfortable with AI in healthcare if hearing about it from their doctors, indicating that doctors are a trusted source of information about such technologies. "It's essential to foster trust of AI-powered technologies among healthcare professionals and patients," said Jasper. "This will enable widespread adoption and effective implementation. Industry-wide collaboration will help us address trust gaps to unlock AI's full potential, enabling responsible, inclusive integration across APAC's healthcare systems." For details on the Future Health Index methodology and to access the full Future Health Index 2025 report, visit Future Health Index | Philips. About the Future Health Index 2025 The Future Health Index is the largest global survey of its kind, analyzing the priorities and perspectives of healthcare professionals and patients across multiple countries. The Future Health Index 2025 investigates how innovative technologies, particularly AI, can empower healthcare professionals to deliver better care to more people. For more information, or to download the full FHI 2025 Global Report, visit About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips' patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2024 sales of EUR 18 billion and employs approximately 67,200 employees with sales and services in more than 100 countries. News about Philips can be found at [1] Global strategy on human resources for health: workforce 2030. 2016 Geneva World Health Organization View original content to download multimedia: SOURCE Royal Philips Sign in to access your portfolio
Yahoo
6 hours ago
- Yahoo
Rockefeller Foundation Releases New Polling Data: Majority of Americans Want Food is Medicine Programs
Nearly 80% of Americans think food and nutrition should be covered by insurance to address chronic disease NEW YORK, June 12, 2025 /PRNewswire/ -- New polling data from The Rockefeller Foundation shows that more than four in five adults in the United States – across demographics, income levels, party affiliations, and geographies – support integrating Food is Medicine (FIM) programs into U.S. healthcare. The survey, conducted by Hattaway Communications, highlights high interest but low public awareness of FIM programs, which aim to treat and manage chronic disease by increasing access to nutritious foods. The research underscores the perceived benefits of Food is Medicine programs, with 79% of respondents reporting that FIM programs would personally help them eat better after they received a definition of the intervention. "Americans want nutrition and food solutions to help them eat better, improve their health, and save money," said Dr. Rajiv J. Shah, President of The Rockefeller Foundation. "We know that these programs are effective in helping patients manage diet-related chronic disease and are cost-effective too. Now, it's even clearer that there is a huge opportunity to improve Americans' health outcomes by investing in low-cost, individualized Food is Medicine solutions that are both proven and popular." Chronic diseases, such as diabetes, obesity, and heart disease, impact an estimated 133 million Americans—more than 38% (or one-third) of the total U.S. population—and cost the United States $1.1 trillion per year (equivalent to what the U.S. spends on food itself). The vast majority of chronic conditions are diet-related: In the United States alone, poor diets contribute to 500,000 deaths annually. Modeling on medically tailored meals shows that investing in FIM programs could save an estimated $32.1 billion a year, significantly reducing Americans' healthcare costs. Even still, only 13% of Americans polled said they knew about FIM programs, which include interventions such as medically tailored meals and prescriptions for accessing fruits and vegetables, coupled with nutrition support. When presented with the definition of what they entail, survey respondents (84%) resoundingly supported the efforts. Some of the key findings include: More than 4 in 5 Americans believe U.S. healthcare should offer more food and nutrition programs to treat and manage illnesses. Nearly 9 in 10 patients would prefer to rely more on healthy eating than on medications to manage their conditions. Nearly 4 in 5 Americans think that Food is Medicine programs should be covered by both public and private insurance, including 85% of self-identified Democrats and 78% of Republicans. 84% of respondents believed FIM could help improve the overall quality of health in the United States. 79% of respondents said FIM programs could help them personally. 49% of the American public and 67% of healthcare workers view high costs of nutritious food as the single largest barrier to eating well. "We are seeing a growing awareness of diet-related diseases and their consequences in the U.S.," said Devon Klatell, Vice President for the Food Initiative at The Rockefeller Foundation. "This polling data shows that Americans want more support to eat well and live well. Food is Medicine programs are one tool that health care practitioners and providers must be considering as they work to address chronic disease in America." The Rockefeller Foundation commissioned Hattaway Communications to conduct the survey, which polled respondents across all 50 states between February 28 and March 11, 2025. The survey sampled 2,271 respondents, including 1,135 patients and 399 healthcare workers. The sample was weighted by gender and education to align with the actual proportions within the population and is representative of racial demographics across the U.S. Since 2019, The Rockefeller Foundation has supported Food is Medicine programs and invested in research to improve their effectiveness and understand the benefits and costs. As part of this effort, The Foundation announced its $100 million investment to expand access to Food is Medicine, including supporting vital research like the American Heart Association's Health Care by Food Initiative. The Foundation also initiated partnerships with the U.S. Department of Veterans Affairs and the U.S. Department of Health and Human Services to speed the integration of Food Is Medicine into health systems. In February 2025, The Rockefeller Foundation announced $3.5 million in grant funding to support small and mid-scale U.S. farmers, improve health outcomes for people with chronic disease, mitigate rising health care costs in California, Hawaii, Maryland, Massachusetts, Mississippi, North Carolina, Oregon, Rhode Island, Virginia, and Washington, D.C., and advance state-based efforts to include FIM interventions as a medically covered benefit under Medicaid programs. About The Rockefeller FoundationThe Rockefeller Foundation is a pioneering philanthropy built on collaborative partnerships at the frontiers of science, technology, and innovation that enable individuals, families, and communities to flourish. We make big bets to promote the wellbeing of humanity. Today, we are focused on advancing human opportunity and reversing the climate crisis by transforming systems in food, health, energy, and finance. For more information, sign up for our newsletter at and follow us on X @RockefellerFdn and LinkedIn @the-rockefeller-foundation. Media Contact:Ashley Chang, The Rockefeller Foundation: media@ View original content: SOURCE The Rockefeller Foundation Sign in to access your portfolio
