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Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.
Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceuticalmanufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.
September 2023 saw a wave of new pharmaceuticalmanufacturing facility expansions and launches across Europe. Research by the Confederation of British Industry (CBI) , released in September this year, highlighted progress for UK manufacturing in its latest Industrial Trends Survey. Meath opened last month.
WASHINGTON — President Biden is using a Cold War-era law to stem drug shortages by boosting domestic pharmaceuticalmanufacturing. Biden announced the initiative at the first meeting of his supply chain resilience council.
In conclusion, because there is “so little nitrite in purified water” using it in drug substance manufacturing processes, “even under acidic conditions and in the presence of vulnerable amines, does not constitute a nitrosamine presence risk for the product in most cases”. The paper was published in Organic Process Research & Development.
Over the past several years, though, these companies have come under increased scrutiny amid concerns that a lack of transparency into their dealings with pharmaceuticalmanufacturers and state Medicaid programs has driven up health care costs for consumers as well as taxpayers.
Pharmaceutical Technology spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceuticalmanufacturing.
An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceuticalmanufacturing firms to conduct surveillance inspections since before the pandemic, raising the risks of contamination and other issues in drugs used by millions of Americans.
Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.
The HPLC method] has value for pharmaceuticalmanufacturing [because it] provides consistent results over time… which is beneficial where batch-to-batch consistency is critical for ensuring product quality and regulatory compliance Their approach has value for pharmaceuticalmanufacturing, the authors stated.
This can lead to refined (bio)pharmaceuticalmanufacturing operations that propel product quality, operational efficiency and overall productivity to new heights. The post Elevating pharmaceuticalmanufacturing processes with real-time insights appeared first on European Pharmaceutical Review.
Therefore, to successfully implement CM in every pharma manufacturing facility, the key focus should be key investments, advancing scientific and technical knowledge, and additional incentives.
The International Federation of PharmaceuticalManufacturers & Associations hailed the outcome. By late last week, when a WTO ministerial conference could have voted on the proposal, the lack of consensus among WTO members was a foregone conclusion.
New regulations, including those put forth by Annex 1, require many pharmaceuticalmanufacturers to rethink their facility designs to promote compliance.
It seeks to identify the factors driving prescription drug costs higher and correlate these to certain expenses, revenue, and profits reported by pharmaceuticalmanufacturers. The Minnesota law, which was enacted in 2020 but strengthened this past May, resembles other so-called transparency laws in some other states.
In the wake of the Covid-19 pandemic, the Food and Drug Administration continues to struggle with a lack of investigators needed to inspect domestic and foreign pharmaceuticalmanufacturing plants and has not yet developed a plan to keep needed staff, a U.S. government watchdog found.
Bringing together over 225+ exhibitors and showcasing 12000+ products and solutions, the expo will represent diverse industries, including pharmaceuticalmanufacturing, biotechnology, medical devices and diagnostics, cosmeceuticals, nutraceuticals, packaging solutions, and healthcare IT.
Specifically, there was a 79% drop in inspections of pharmaceuticalmanufacturing plants in foreign countries and a 35% decline in domestic facilities from 2019 to 2022. Meanwhile, FDA budgeting and staffing held steady, although resources allocated for each inspection surged and more plants were cited for serious violations.
As the sector continues its rapid expansion, with a 7 per cent annual growth rate, the event will highlight the increasing reliance on contract development and manufacturing organisations (CDMOs) in bringing new therapies to market.
senators sent letters to five telehealth companies that offer care through direct-to-consumer portals from pharmaceuticalmanufacturers Pfizer and Eli Lilly, interrogating their financial relationships , STAT tells us. Best of luck, and do keep in touch… A group of U.S.
Based on CareMetx research, he outlines the key factors that drug manufacturers value in their hub partners. Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir discusses how hubs help patients initiate and adhere to drug therapies.
This initiative was a collaborative effort by AIPAC, the Society for Pharmaceutical Dissolution Science (SPDS), the Indian Drug Manufacturers Association (IDMA-MP), and the Madhya Pradesh State Drugs and PharmaceuticalManufacturers Association (MPSDMA). The programme was led by S.
Other efforts include a boost in mental health clinical research and investments in pharmaceuticalmanufacturing technology and workforce development, as well as a plan to grow and streamline industry clinical trials — a key point of concern as the U.K. has fallen behind other countries in running such studies.
The law requires pharmaceuticalmanufacturers, wholesalers, and pharmacies to install the equivalent of electronic health records to track transactions in hopes of making it easier to detect phony medicines and, crucially, identify the point at which they enter the supply chain.
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?
This link in the pharma supply chain is undergoing a major transformation propelled by technological advancements, regulatory changes, and evolving market dynamics, requiring industry leaders to adopt innovative strategies in order to remain competitive.
This milestone underscores our commitment to upholding the highest standards of quality and compliance, solidifying our position as a leading pharmaceuticalmanufacturer. Nilesh Gupta, Managing Director of Lupin, stated, We are very pleased to have received the EIR for our Somerset facility.
Roquette Pharma Solutions' Christine Mya-San, global account manager, highlights the most significant pharma ingredients at play over the past year and discusses future ingredient innovation.
Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceuticalmanufacturing firms to conduct surveillance inspections since before the pandemic, raising the risks of contamination and other issues in drugs used by millions of Americans. An analysis of U.S.
Saransh Chaudhary, President of Global Critical Care at Venus Remedies and CEO of Venus Medicine Research Centre, commented on the achievement, stating, “Securing the PIC/S GMP accreditation from Malaysia’s NPRA is a significant milestone and a testament to our commitment to quality and technological innovation in pharmaceuticalmanufacturing.
The PMEC pavilion featured advanced pharmaceuticalmanufacturing technologies from companies like ACG, Accupack Engineering, and Fette India. Exhibitors included key players such as Dr Reddy’s Laboratories, Biocon, Glenmark Lifesciences, Morepen Laboratories, Hetero Labs, Lupin, and Merck Life Science.
Or they may share in the rebates that the PBMs pluck from pharmaceuticalmanufacturers — money that otherwise could be used by employers to lower premiums for their workers. Consulting firms and brokerages may receive a certain dollar amount for each covered employee and member.
The success of mRNA vaccine technology could be one of the new opportunities for US pharmaceuticalmanufacturing looking forward, with pandemic investments helping turbocharge the sector.
Scheduled to take place from January 27-30, 2025, at the World Trade Center (WTC), Dubai to be inaugurated by Satish Kumar Siven, Consul General of India to UAE, at Dubai on January 27, 2025 this event will feature participation from 65 leading Indian pharmaceutical companies.
Pharma Tech Industries, a pharmaceuticalmanufacturing and packaging solutions contractor for wellness products and medical devices, has announced the appointment of their new chief executive officer Darrin T Schellin. “I am honoured to join Pharma Tech Industries at such an exciting time in its journey,” said Mr Schellin.
A recent article published in Health Affairs, delves into the Federal Trade Commission’s (FTC) concerns regarding the inclusion of improper patents in the FDA’s Orange Book by pharmaceuticalmanufacturers.
Based on the new cost estimates, pharmaceuticalmanufacturers in Finland alone will be required to fund 280816 million of these expenses, The directive , enforced on 1 January 2025, imposes an extended manufacturer responsibility on the removal of micro-pollutants from wastewaters.
As an outsider, finding out the manufacturing capacity of a given pharmaceuticalmanufacturing plant can be challenging due to the proprietary nature of such information.
Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.
To find Key Starting Materials (KSMs) for pharmaceutical Active Pharmaceutical Ingredients (APIs), you can follow these steps: Remember that the availability and sourcing of KSMs can vary depending on the specific API and regulatory requirements in different countries.
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