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Need some raw material pharmacopeia monograph testing? Yes, yes you do. Contact Us, before you poison someone, to Learn More!: "Ingredients of the drugs registered as manufactured at your firm include ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution ... The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide." (see FDA Warning Letter below) #21cfr #cfr #fda #fdaapproval #fdaapproved #pharmaceutical #pharma #law #litigation #litigation #litigationsupport #regulatoryaffairs #regulatorycompliance #cmc #mrna #mrnavaccines #geneediting #genetherapy #genetics #cannabislaw #cannabis #cannabisindustry #cannabisnews #cannabisbusiness #psychedelics #pharmaceutical #pharma #psychedelicscience #mentalhealth #mentalhealthawareness #clinicaltrials #clinicalresearch #cartcelltherapy #cancerresearch (https://lnkd.in/gh9GAdsm)

Cold Chain – importance in Pharmaceuticals   The cold chain plays a crucial role in maintaining the quality and efficacy of pharmaceutical products, especially those that are temperature-sensitive, such as vaccines, biologics, and certain medications. The importance lies in the following reasons 1.    Preservation of Product Integrity and therefore Product Efficacy 2.    Ensuring Patient Safety 3.    Regulatory Compliance 4.    Minimizing Product Loss and Waste 5.    Supporting Global Distribution I am sure that this area will be important in a big way for Indian Pharmaceutical Industry and even globally where the percentage of Biologics and Biopharmaceuticals drug products is increasing by the day. This will open up new opportunities for logistics companies across the world. For sure this is a capital and cost-intensive area. Therefore the Pharma companies need to collaborate with the logistics companies that have the infrastructure in place to offer optimum customised solutions. The solutions for proper storage and handling in multi-modal transportation and distribution will be critical to product integrity and efficacy in the entire supply chain, especially the last mile until the drug product is administered to the patient. We are in for a great evolution in this space in the coming years as it is not only the Pharma industry but will have applications for all perishables whether food, fruits, beverages, meat, poultry etc.

This overview by Guriqbal Singh describes the patchwork regulations for biosimilar developers in the Middle East and North Africa. These countries are among the most active in the world for #biosimilar drugs. https://lnkd.in/emmH47Xm #pharmaceuticalmanufacturing #middleeast

India has become a global powerhouse in generic medicine production, offering bioequivalent alternatives to branded drugs at a fraction of the cost. Being a key player in generic drug manufacturing, India faces a challenge hindering timely access to new medicines: patent backlogs. The surge in pharmaceutical patent applications strains the patent office, causing delays. India needs increased staffing, modernized infrastructure, and streamlined processes to address this. Investing in a robust patent examination system is crucial, involving recruitment, training, technology integration, and specialized divisions to expedite approvals and foster innovation in the pharmaceutical sector. Read the new blog on www.unitedandunited.com, providing an analytical study of how India can cop with such a situation - https://lnkd.in/d7TGJ-sS #patent #pharmaceutical #pharmaceuticalindustry #india #indianmanufacturer #genericdrugs #worldleaders #intellectualproperty #iplaw #iplawyer #lawstudent

🚀 Transforming Drug Substance Development and Manufacture with ICH Guideline Q11 The pharmaceutical landscape is evolving rapidly, and at the heart of this evolution lies ICH Guideline Q11, shaping the development and manufacture of drug substances. Let's delve into the insights this guideline offers for optimizing processes and ensuring regulatory compliance. Embracing the principles outlined in ICH Guideline Q11 is crucial as the industry progresses, fostering innovation, maintaining quality standards, and ultimately enhancing patient outcomes. Examples of Implementation in ICH Guideline Q11: 🔍 Chemical Entities: Development and manufacture of chemical entities, including synthetic drugs, with a focus on optimizing synthetic routes and controlling impurities. 🔍 Biotechnological/Biological Entities: Guidelines for the development and manufacture of biotechnological and biological entities, including recombinant proteins and monoclonal antibodies, emphasizing process control and characterization. #DrugSubstanceDevelopment #ICHQ11 #PharmaInnovation #RegulatoryCompliance #ProcessOptimization #QualityManagement #AmaliaTech ✅ Like ✅ Repost ✅ Comment ☑ Follow us for more! Engaged in drug substance development? 💬Share your experiences and insights in the comments below! Seeking expert advice? 🤝Reach out to Niki Sorogas, PhD and Dimitra Kourtidou for tailored solutions!

[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

𝐀𝐜𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐈𝐧𝐠𝐫𝐞𝐝𝐢𝐞𝐧𝐭𝐬 (𝐀𝐏𝐈) 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲: 𝐀𝐧 𝐄𝐱𝐩𝐨𝐧𝐞𝐧𝐭𝐢𝐚𝐥𝐥𝐲 𝐆𝐫𝐨𝐰𝐢𝐧𝐠 𝐒𝐞𝐜𝐭𝐨𝐫 𝐂𝐥𝐢𝐜𝐤 𝐭𝐨 𝐑𝐞𝐪𝐮𝐞𝐬𝐭 𝐏𝐃𝐅 𝐂𝐨𝐩𝐲 -https://lnkd.in/gqccEb69 (Use Corporate Mail Id for Quick Response) An active pharmaceutical ingredient (API) is any substance or mixture of substances used in the finished pharmaceutical product (FPP) that is intended to provide pharmacological action or to otherwise have a direct impact in the diagnosis, remedy, mitigation, therapy, or prevention of disease, or to have a direct effect in repairing, correcting, or altering physiological functions in humans. Active pharmaceutical ingredient (API) refers to the active component in a drug. In simple terms, API is part of any drug that produces the intended effects. Drugs are usually formed from several components. The API acts as the primary ingredient. Other ingredients are commonly called excipients, and these elements are required to be biologically innoxious, often forming a changeable fraction of the drug product. Rise in prevalence of diseases & disorders and growth in government & organizational investments to develop APIs are major contributors to the expansion of the global active pharmaceutical ingredients (API) market. In addition, advancements in research & technology on biological processes and small molecule APIs are expected to prove beneficial for the increasing market demand. 𝗦𝗼𝗺𝗲 𝗸𝗲𝘆 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗻𝗴 𝗶𝗻 𝘁𝗵𝗲 𝗴𝗹𝗼𝗯𝗮𝗹 𝗺𝗮𝗿𝗸𝗲𝘁: ♦Merck Group ♦Teva Pharmaceuticals ♦Sanofi ♦Pfizer ♦Novartis ♦Mylan ♦Lonza ♦WuXi AppTec ♦Piramal Pharma Solutions ♦Ipca Laboratories Limited and More... #api #activepharmaceuticalingredients #pharmaceuticals #drugdevelopment #pharmaceuticalmanufacturing #drugingredients #drugformulation #apiproduction #pharmaceuticalsupplychain #pharmaceuticalregulations #china #india #singapore #malaysia #japan #thailand #southkorea #australia #us #uk #usa #russia #canada #germany #northamerica

Dr. Nutan Rao, Associate Professor, alongwith her co-authors, Roshani Powar have published a review paper entitled "Post marketing drug Withdrawals: A review" The review article is published in Pharmaceutical Chemistry Journal. The emergence of new diseases demands high-speed drug development. Drug development is a long and tedious process. As research for medicine goes on several changes occur in the process of drug development. In order to promote safe and proper use of drugs with the fewest side effects, black box warnings are given to the drugs. Many times, these drugs must be removed at the final stage of marketing owing to the many adverse effects found during drug development. Hence, it is important for every newly developed drug to be safe for people and ideally to have no side effects. This review describes the black box warnings issued by the Food and Drug Administration (FDA) for certain drugs and the reasons for some of the post-marketing drug withdrawals. Most of the post-marketing drug withdrawals are a result of unanticipated or unprecedented adverse drug effects. #vescop #vescollegeofpharmacy #publication #alert #pharmaceutical #chemistry #drugdiscovery

📚 Exciting News! Our latest review article, "A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products" has been published in Volume 13, Issue 4 of the prestigious International Journal of Pharmaceutical Investigation (IJPI). 👥 I had the privilege of collaborating with an exceptional team. 🙏I want to express my gratitude to our mentors, Dr. K. Venkateswara Raju and Dr. Lakshmi Prasanthi Nori, for their unwavering support. I want to thank my co-authors Anusha Penamacha, Bhanu Mounika Somalanka, and the IJPI editorial board for this opportunity. 💊 Nitrosamines in drug products have been a topic of significant concern, and these Nitrosamines are a class of potentially harmful substances that can form in certain drug products, posing a significant concern to public health. Our article not only highlights the challenges posed by nitrosamine impurities but also offers valuable insights into the regulatory landscape governing their presence, ensuring that pharmaceutical products are safe and effective for patients worldwide. 📖 You can read the full article here https://lnkd.in/gRD9vzBe 📣 I invite all my connections to look at our review, and I'm eager to hear your thoughts and engage in discussions on this critical issue. Let's work together to advance pharmaceutical safety and regulation! #Pharmaceuticals #Nitrosamines #NitrosamineImpurities #DrugSafety #Regulations #IJPI #Science #Collaboration #DrugDevelopment

[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