ISPE’s Post

Exciting developments are unfolding in Vietnam's pharmaceutical sector! 📊 The industry is undergoing a massive digital transformation, with all drug information being centralized in a comprehensive Pharmaceutical Industry Data Bank. Key highlights: 214 pharmaceutical factories 185 companies with valid production licenses 100% level 4 online public services integrated into the National Portal AI applications in pharmaceutical activities Ambitious goal: 4.0 pharmacists per 1,000 people (20% clinically trained) Get PDF- https://lnkd.in/gQTwzjkA The market is booming, valued at $7.60 Billion in 2023 with a projected CAGR of 7.96% through 2029. Driving factors include: Growing and aging population Rising incomes Improved healthcare infrastructure Government initiatives promoting domestic production Increasing prevalence of chronic diseases Are you part of this exciting transformation? How do you see AI and digitalization shaping the future of pharmaceuticals? Let's discuss in the comments! Bayer Vietnam Ltd. DHG Pharmaceutical Joint Stock Company Traphaco Joint Stock Company Pharmaceutical Corporation Ha Tay Domesco Medical Import Export Joint Stock Corporation (DOMESCO) OPC Pharmaceutical Joint Stock Company (OPC) Sanofi Vietnam MEKOPHAR Chemical and Pharmaceutical JSC Imexpharm Pharmaceutical Joint Stock Company (IMEXPHARM) Pymepharco Joint Stock Company #DigitalTransformation #Pharmaceuticals #Vietnam #Healthcare #AI"

[Free Webinar Academy Webinar _ Sept 14, 2023 | 14:30 CEST| 18:00 IST ] Marc Vorderman and Rajasekhar Gollapinni at Caliber Technologies will discuss the processes and methods of avoiding and mitigating contamination risks. Microbial monitoring is crucial for #drugsafety in the pharmaceutical industry. It helps identify and mitigate potential contamination sources, ensuring clean manufacturing environments and minimizing the risk of microbial contamination in raw materials, processed, and finished products. Do not miss this free webinar!  #environmentalmonitoring #contaminationcontrol https://lnkd.in/dzf4Am47

[Free Webinar Academy Webinar _ Sept 14, 2023 | 14:30 CEST| 18:00 IST ] Marc Vorderman and Rajasekhar Gollapinni at Caliber Technologies will discuss the processes and methods of avoiding and mitigating contamination risks. Microbial monitoring is crucial for #drugsafety in the pharmaceutical industry. It helps identify and mitigate potential contamination sources, ensuring clean manufacturing environments and minimizing the risk of microbial contamination in raw materials, processed, and finished products. Do not miss this free webinar!  #environmentalmonitoring #contaminationcontrol https://lnkd.in/dzf4Am47

[Free Webinar Academy Webinar _ Sept 14, 2023 | 14:30 CEST| 18:00 IST ] Marc Vorderman and Rajasekhar Gollapinni at Caliber Technologies will discuss the processes and methods of avoiding and mitigating contamination risks. Microbial monitoring is crucial for #drugsafety in the pharmaceutical industry. It helps identify and mitigate potential contamination sources, ensuring clean manufacturing environments and minimizing the risk of microbial contamination in raw materials, processed, and finished products. Do not miss this free webinar!  #environmentalmonitoring #contaminationcontrol https://lnkd.in/dzf4Am47

Meet our team of experts at BioAsia 2024, the premier life sciences and healthcare forum organized by the Government of Telangana to know more about how we can partner with you in accelerating your molecule’s journey to commercialization. Aragen offers end-to-end solutions across the drug discovery, development and manufacturing continuum. Analytical Solutions play a crucial role in ensuring the quality of the product, safeguarding patient well-being, and preventing product deterioration. Regulatory bodies mandate manufacturers to assess the microbial quality of both active and excipient pharmaceutical substances. Manufacturers must characterize the manufacturing and handling processes of their drug products to manage and eliminate contamination risks. Aragen's Analytical Solutions are phase-appropriate and iterative, focusing on continuous improvement so that the developed and validated methods support the progress of the drug candidates. Our Analytical Solutions offerings include Quality Control & Release Testing, Analytical Method Development & Validation, Stability & Photo Stability Testing, Storage & Management Impurity Profiling & Elemental Analysis, Microbiology Physicochemical Characterization, Dissolution Testing Extractable & Leachable studies, and Stability studies. To know more about Aragen’s Analytical Solution offerings, meet our team at booth S4 or write to us at info@aragen.com #event #host #industry #analytical #solutions #lifesciences #healthcare #endtoendsolutions #molecules #drugdiscovery #drugdevelopment #aragen #pharmaceuticals

The description, assessment and documentation of impurities in drug substance, excipients, drug product and packaging material are an essential part of the quality and safety of a drug during its life cycle. The main frame and rules are documented in official guidelines and pharmacopoeias; however, not all relevant aspects are covered by the regulatory documents. One of these emerging but often neglected topics is the burden of microplastics in medicinal products and the environment and its proper handling and documentation.   In September 2022 the European Commission published a draft regulation to amend Annex XVII to Regulation (EC) No 1907/2006 regarding the use of synthetic polymer microparticles after publication in 2020 of the Annex XV Restriction proposal on intentionally added microplastics by European Chemicals Agency (ECHA).   For more information and to register, please follow this link: https://lnkd.in/eAEJDEds   LIVE Webinar on 30/11/2023 | 10:00 – 11:30 CET Duration in total: approx. 90 minutes Language: English | Slides: English Single person booking: 295.00 EURO plus VAT   The following aspects will be presented and discussed: ● Sources, fate and effects of microplastics in the marine environment – a global assessment ● Microplastics regulation – an overview of regulations Proposed EU rules on small particles ● EFPIA - European Federation of Pharmaceutical Industries and Associations position on the ECHA microplastics restrictions ● How to document according to the proposal for an EU-wide restriction on intentionally added microplastics. ● Implications for pharmaceutical excipients, medicinal products and food additives ● Presence of microplastics and nanoplastics in food and pharmaceuticals ● Recommendations for quantifying synthetic particles in pharmaceutical drug substances and products ● Interaction between microplastics and pharmaceuticals, depending on the composition of the aquatic environment ● Physicochemical properties of microplastics, specific adsorption modeling and their interaction with pharmaceuticals and other emerging contaminants ● Future regulatory landscape for pharmaceutical excipients: nanoparticles and microplastics   #impurities #microplastics #nanoplastics #

The description, assessment and documentation of impurities in drug substance, excipients, drug product and packaging material are an essential part of the quality and safety of a drug during its life cycle. The main frame and rules are documented in official guidelines and pharmacopoeias; however, not all relevant aspects are covered by the regulatory documents. One of these emerging but often neglected topics is the burden of microplastics in medicinal products and the environment and its proper handling and documentation.   In September 2022 the European Commission published a draft regulation to amend Annex XVII to Regulation (EC) No 1907/2006 regarding the use of synthetic polymer microparticles after publication in 2020 of the Annex XV Restriction proposal on intentionally added microplastics by European Chemicals Agency (ECHA).   For more information and to register, please follow this link: https://lnkd.in/e-wXWruV   LIVE Webinar on 30/11/2023 | 10:00 – 11:30 CET Duration in total: approx. 90 minutes Language: English | Slides: English Single person booking: 295.00 EURO plus VAT   The following aspects will be presented and discussed: ● Sources, fate and effects of microplastics in the marine environment – a global assessment ● Microplastics regulation – an overview of regulations Proposed EU rules on small particles ● EFPIA - European Federation of Pharmaceutical Industries and Associations position on the ECHA microplastics restrictions ● How to document according to the proposal for an EU-wide restriction on intentionally added microplastics. ● Implications for pharmaceutical excipients, medicinal products and food additives ● Presence of microplastics and nanoplastics in food and pharmaceuticals ● Recommendations for quantifying synthetic particles in pharmaceutical drug substances and products ● Interaction between microplastics and pharmaceuticals, depending on the composition of the aquatic environment ● Physicochemical properties of microplastics, specific adsorption modeling and their interaction with pharmaceuticals and other emerging contaminants ● Future regulatory landscape for pharmaceutical excipients: nanoparticles and microplastics Norbert Handler Helmut Buschmann   #impurities #microplastics #nanoplastics #

The API market is experiencing consistent growth, driven by factors that contribute to the expansion of the global pharmaceutical supply chain. Size of the global active pharmaceutical ingredient market revenue was estimated to be $163.5 billion in 2024 and is projected to reach $238.3 billion by 2029, with a CAGR of 7.8% from 2024 to 2029. Here are Some Key trends that shape the API market: 1. Noticeable shifting towards the production of high-potency APIs (HPAPIs), driven by their efficacy in treating diseases like cancer. That demand for HPAPIs is increasing investments in specialized manufacturing facilities equipped with state-of-the-art production technologies. 2. Biologics and biosimilars, which significantly influencing the API market & the whole industry. Biologic drugs, derived from living organisms, require intricate and precise API production processes. The expiration of patents for many biologic drugs is creating opportunities for biosimilar production, further driving this trend. 3.Positive reinforcement of generic drug development is boosting the API market. Governments worldwide are promoting the production of generics to reduce healthcare costs, resulting in high demand for APIs. Finally, Manufacturers are embracing environmentally-friendly methods to reduce their ecological impact, adhere to regulations, and safeguard the industry's long-term sustainability. Which makes the adoption of green chemistry practices is considered as one of the increasingly important trends in the API market. #ActivePharmaceuticalIngredients #Innovation #HealthCare #OHC #Pharma #OverseasrHealthcareConnectors #Biologics #Biosimilars #CAGR #PharmaceuticalSupplyChain #Sustainability

The following is a high-level process organogram for China depicting an overview of the approval process for medicines (non-biological/ chemically synthesized drug moieties as well as biological products) for human use:  The conditions for creating, registering, and approving a pharmaceutical product in China depend on the following classification: • Chemical medication • Biological substances • Chinese traditional medicine Each type is then divided into three registration and approval categories, which specify the items that the applicant must provide as part of its registration application, such as a clinical trial application, a marketing authorization application, and so on. The registration and approval categories for chemical medications are as follows: • Innovative drugs • Improved new drugs • Generics The registration and approval categories for biologics are as follows: • Innovative biological products • Improved new biological products • Marketed biological products (including biosimilars) The clinical trial application assessment and approval process is determined by the drug category in which an applicant chooses to register. • Breakthrough approval • Priority review • Conditional approval • Special approval 🎯Are you looking for a reliable partner for the sourcing of Comparator drugs from global markets for your clinical trials and BA/BE studies? 🌐Website: www.springbiosolution.com 📧Email: bd@springbiosolution.com #SpringBioSolution #SpringBio #ClinicalTrialSupplies #BiologicalDrugs #ChemicallySynthesizedDrugs #OrphanDrugs #DrugApprovalProcess #DrugsApprovalProcessChina #DrugDevelopment #ReferenceListedDrugs #GenericDrugs #RLDs #GenericMedicines #ComparatorsDrugs #ComparatorSourcing #ComparatorDrugsSupplier #RldSupplier #GlobalPharma #Pharmaceuticalindustry

The specialized treatments required by 21st century medicine can only be achieved through highly sophisticated pre-clinical pharmacological research. Today, such research is truly global, involving program-critical ingredients and suppliers from all corners of the world. In 2017, Biocair began transporting API shipments from China to the US for a small, independent US-based research company focusing on innovative drug treatments. Over the years, Biocair's logistical support facilitated the progression of their drug development program from initial research, through clinical trial to Food and Drug Administration (FDA) submission and approval. What kind of logistical support did this require? 🧪 Maintaining drug development program continuity through mergers and acquisitions 🧪 Developing scalable packaging procedures 🧪 Providing expertise in exporting shipments from China and importing these to the US 🧪 Ensuring the proper classification and declaration of dangerous goods Learn more about the role that Biocair played in the success of this global drug development program in our most recent case study 👇 https://hubs.li/Q02sv_X70 #API #FDA #pharmaceutical #drugdevelopment #preclinical #movingscienceforward