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He highlighted that India’s pharmaceutical industry holds a global reputation, but sustaining this leadership requires a strong commitment to compliance, transparency, and continuous improvement in managing change control and deviations. In-depth presentation: The expert education session, conducted by Rajendra N.
Revolutionising pharma the adaptive way Pharmaceuticalmanufacturing is undergoing a transformative development, driven by innovative technologies that enable right-first time (RFT) production and adaptive scaling to meet changing demands. Why is adaptive manufacturing necessary?
63 per cent of CXOs highlighted the need for a single global product standard, which would not only improve the quality of pharmaceuticals but also streamline manufacturing processes and elevate compliance levels. There should be transparency in all reporting.
What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceuticalmanufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.
This framework delivers a clear strategy for companies to incorporate digital technologies, enable real-time release for drug manufacturing and address key challenges such as data silos and integrating legacy infrastructure, according to CPI.
Leverage advanced pharmaceuticalmanufacturing technologies for more efficient production of these medicines. This geographic clustering creates significant supply chain vulnerabilities, especially for essential generic medicines. Making the U.S. or multiple geographies. Making the U.S. or multiple geographies.
Over half of the active pharmaceutical ingredients (API) for prescription medicines in the U.S. come from India and the European Union This blog is part of a series on the geographic concentration of pharmaceuticalmanufacturing. This blog focuses on the manufacturing of active pharmaceutical ingredients (API).
New research reveals that while 52 percent of pharmaceutical companies remain in early stages of digitalisation, leading manufacturers are finding innovative ways to overcome data fragmentation and drive operational efficiency. The pharmaceuticalmanufacturing sector stands at a digital crossroads.
He also underlined the importance of safeguarding proprietary information and avoiding unauthorised process changes. Looking Ahead: The next session in the PULSE psorias is focusing on Management of Essential Contracts in Pharmaceuticalmanufacturing.
In fact, HCPs now expect tailored, relevant, and timely information delivered across multiple touchpoints. Similarly, pharmaceuticalmanufacturers increasingly rely on digital media alliances, real-world data vendors, and value-based care consultants to support commercialization strategies.
The session focused on the manufacture of sterile drug products in line with the Revised Schedule M, bringing together key stakeholders and experts from across the pharmaceuticalmanufacturing ecosystem. Dr Birendra Singh, Senior President and Global Quality Head at Mankind Pharma, delivered the keynote address as Chief Guest.
Continuus Pharmaceuticals, a spin-out company from a multiyear collaboration between MIT and Novartis, specializes in end-to-end integrated continuous manufacturing. For more than 20 years, Greg has covered the healthcare, life sciences, and medical device industries for several trade publications.
The Advanced Technologies Lab will help industry and regulators accelerate the adoption of new technologies that help to mitigate supply chain risks and, where appropriate, establish guidance that supports regulatory predictability, process efficiencies, and faster time to market, all of which can strengthen domestic manufacturing capabilities.
Artificial intelligence addresses key limitations of traditional health technology assessments—such as data gaps and time-intensive processes—through automation, real-time data integration, and advanced predictive modeling, leading to faster and more informed decisions. AI supports personalized medicine and real-world evidence integration.
Implementing PAT in (bio)pharmaceuticalmanufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. GMP Audits in Pharmaceutical and Biotechnology Industries.
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Asembia 2025: Navigating the Product Commercialization Process Nicholas Saraceno, Editor April 29th 2025 Article Brett Casper explores the marketplace complexities that manufacturers face regularly.
For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceuticalmanufacturer has to show bioequivalence to the reference product,” Soefje said. “If Subscribe Now!
Concluding reflections on the series This 3-part series has explored India’s evolving role as a global hub for sterile pharmaceuticalmanufacturing through the lens of U.S. The challenges faced by Indian sterile manufacturers are not merely technical; they are strategic, cultural, and systemic. FDA oversight.
Over a century of experience bringing together patient organizations, caregivers, providers, and innovator informs our ability to advocate for policies that anticipate and address the needs of patients across the American health care system. Food and Drug Administration, Importing Biologics and CBER Regulated Products.
3,4 How this pricing model will be implemented and whether pharmaceuticalmanufacturers will be able to meet the expectations of the 2025 executive order, if upheld, is uncertain. The order states that if manufacturers are unable to meet the 30-day deadline, the secretary of the Department of Health and Human Services, Robert F.
This involves close coordination with specialty pharmacies, infusion services, retail pharmacies, pharmaceuticalmanufacturers, medication access programs, and industry representatives. Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.
Drug tracking data, purchasing information, and usage trends can all be meaningfully applied to build models that generate actionable insights that enhance efficiency, ensure that therapies are available when and where they are needed, enable smarter inventory control, and improve predictive analytics.
The US Food and Drug Administration (FDA) has unveiled plans to encourage the construction of new pharmaceuticalmanufacturing facilities as part of its push to strengthen the country’s domestic supply chain.
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Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
The industry's dependence on geopolitical stability and predictable trade relationships is increasingly critical for global pharmaceuticalmanufacturing. Information collected by Sponsor in connection with this Sweepstakes may be used by Sponsor and shared with third parties involved in administration of the Sweepstakes.
We have evidence of foreign manufacturers cutting corners and having less than high-quality standards.” 26 – Eli Lilly and Company announces that it will be constructing four new pharmaceuticalmanufacturing sites in the United States, representing financial commitments in the expansion space exceeding $50 billion since the start of 2020.
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Understand the minimum information required for enrollment Hub enrollment can often be completed with just five “minimum viable enrollment” fields: first name, last name, date of birth, sex, and zip code. As a result, we envision a near-term future when the entire onboarding process is accomplished with even greater operational efficiency.
Key Takeaways A formal trade agreement between the US and EU introduces a 15% tariff on most EU exports, including pharmaceuticals, potentially costing the pharma sector $13 billion–$19 billion. Experts recommend stockpiling medications and using forecasting tools to navigate tariff uncertainty and mitigate potential supply disruptions. “The
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceuticalmanufacturers which could further strain the healthcare safety net and patient care services. For more information on evaluating your existing contract pharmacies, click here. Additionally, up to $8.4
In this first segment of a multi-part interview, Jason Waite, international trade expert at Alston & Bird, outlines how recent United States tariff activity could significantly impact pharmaceuticalmanufacturers. It may contain errors, informal language, or omissions as spoken in the original recording.
A new state-of-the-art facility in Virginia will produce active pharmaceutical ingredients (APIs) for weight management and metabolic treatments, leveraging AI, automation, and data analytics. 2 He described it as being a “low tariff” that would slowly increase over the course of approximately a year.
5 The Most Significant Driver of Health Care Spend Isn’t Drugs—It Isn’t Even Close Pharmaceuticalmanufacturers are a frequent punching bag for politicians, mostly because they are easy targets, and they tend to have more visible out-of-pocket exposure. Subscribe Now!
Actio Biosciences CEO and co-founder David Goldstein stated: “We have made tremendous progress across our pipeline – executing a precision medicine strategy that targets the root causes of disease through genetically informed drug development. Give your business an edge with our leading industry insights.
Author(s): Christopher Cole Key Takeaways Bio/pharmaceuticalmanufacturers are strained by evolving trade policies and tariffs, affecting profits and operational strategies. Tariffs disrupt the flow of finished products and raw materials, complicating compliance and cost forecasting. Share your voice!
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
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