Recently, Suzhou Jingye Medicine & Chemical Co., Ltd. (Jingye) successfully obtained the "Approval Notice for the Market Launch of Chemical Raw Materials" (Notice No. 2024YS00864) issued by the National Medical Products Administration (NMPA) for its gadopentetate chemical raw material. The approval of the gadopentetate raw material is not only another milestone in Jingye's research and development capabilities but also further evidence of the deep collaboration and shared success between Jingye and Shanghai Medicilon Inc. (Medicilon). 🤝 👍
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I would like to share my experience where I participated in the 8th International Conference on Pharmacy and Advanced Pharmaceutical Sciences (ICPAPS 2023) as a participant in an oral presentation. On that occasion, I conveyed my research with Mrs. Chairun Wiedyaningsih related to Factors Determining Consumers' Decisions to Purchase Topical Analgesic for Musculoskeletal Disorders in Indonesia. This research is an interesting topic where my research explains that psychological, social, cultural, and personal factors can influence drug purchase decisions, especially topical analgesic, which is one of the high-demand products and is widely spread in the Indonesian market. If you are interested in reading more, then you can read my journal paper available at https://lnkd.in/gQ4NdFDA.
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We received this question from a new customer comparing our product to a third-party product. How do we respond to ensure customers can see the clear difference? For privacy, we redacted the name and contacts. Our response, based on our robust preclinical and clinical research, as well as regulatory clearances, is as follows: SKF7® is an aqueous ethanolic extract of Labisia pumila standardized to NLT 2% Gallic Acid. Our SKF7® is the only product in Malaysia that has received clearance from the US FDA and EFSA/EU. The preclinical studies on obesity were initially conducted by USM, followed by human clinical trials in individuals with obesity conducted by Medika Natura Sdn Bhd. The major differences between our SKF7® and any other Kacip Fatimah in the market are as follows: 1. Our SKF7® clinical data is published in a peer-reviewed medical journal, unlike other products lacking human clinical data. 2. Our SKF7® safety data is independently scrutinized and reviewed by NPRA, US FDA, and EFSA, ensuring a high level of regulatory clearance compared to other products. 3. Our SKF7® is manufactured under GMP PIC/s, ensuring pharmaceutical-grade quality. 4. Our SKF7® is standardized to NLT 2% Gallic acid, whereas other products may lack standardization or clarity on active compounds. Regarding dosage, our clinical findings demonstrate an incremental reduction in WC and WHtR consistent with the gradual increase in the total daily concentration of SKF7® from 375 to 750 mg. Therefore, we recommend taking 2 capsules a day, up to a maximum of 4 capsules per day. For more information, you can refer to our human clinical publication here https://lnkd.in/gg_iQTr4, conducted in MOH's hospitals and clinics, and our EFSA publication here https://lnkd.in/gNfA4MXB. Regarding the 3rd party product, we cannot comment beyond our understanding of their formulation, but essentially, theirs is a water extract and different from our SKF7® as stated above. #womenhealth #metabolichealth #clinicallytested #kacipfatimah
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Strengthening Your Drug IP: The Power of Conformational Epitope Mapping Conformational epitope mapping goes beyond traditional methods by revealing the 3D structure of how a drug binds to its target protein. This detailed picture offers a powerful advantage: it strengthens your IP claims. By showing that your drug binds to a unique region on the target protein compared to existing drugs, epitope mapping establishes novelty. Furthermore, epitope mapping helps prove non-obviousness, a key patent requirement. It unveils the specific amino acids critical for binding, showcasing the drug’s efficacy isn't a minor tweak but a specific interaction. Conformational epitope mapping provides compelling evidence for your drug's uniqueness and effectiveness, paving the way for robust IP protection. Reach out to us today to see how we can help! #drugdiscovery #IP #epitopemapping #drugIP
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Listen to this doctor's view on the effectiveness of botanicals versus synthetics in treating certain diseases, and how China integrates the two approaches. Recently, when we were consulted by the School of Pharmacy at the University of Malaya regarding their new master's program related to the clinical and pharmaceutical application of botanical medicine, we suggested that the program be changed from Master in Traditional Medicine to Master in Integrative Medicine. This is because the world is moving toward integrated healthcare solutions; diseases are becoming more complex, issues with synthetic drug resistance and side effects, among many others, prompt us to provide more options derived from natural sources. In simple words, There Is No One-size-fits-all #integrativemedicine #china #indonesia
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*JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs* The JP and the Ph. Eur. announce the launch of a bilateral prospective harmonisation project targeting pharmacopoeial standards for active substances and medicinal products. Pharmacopeial harmonisation serves to further reduce the burden on manufacturers to perform different compendial tests by aligning the pharmacopoeial standards in different regulatory jurisdictions. Since the launch of the Pharmacopeial Discussion Group (PDG) in 1989, the JP and Ph. Eur., together with the United States Pharmacopeia and more recently the Indian Pharmacopoeia, have been working on the retrospective harmonisation of general chapters and excipient monographs. This new bilateral prospective harmonisation project will take place outside of the PDG processes and will build upon the experience gathered over the many years of collaboration between JP and Ph. Eur. to apply it to the elaboration of active
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I just read a fascinating article on the integration of the Analytical Procedure Lifecycle (APLC) concept in qNMR. This article provided an excellent example of how qNMR can be made compatible with a life cycle approach for qNMR method development and validation. Its conclusions lend further support to the newly proposed USP NMR chapters. Really enjoy having time to read articles like this one. https://lnkd.in/eS95aX-Z #qNMR #PharmaceuticalAnalysis #HerbalMedicine #USPNMR #InnovationInPharma #LifeCycleApproach
Application of the Analytical Procedure Lifecycle Concept to a Quantitative 1H NMR Method for Total Dammarane-Type Saponins
ncbi.nlm.nih.gov
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While we embrace the decade and clinical benefits of 225Ac, it is now time to prepare for the next generation of (shorter half-life) radiopharmaceuticals
As the R&D and the clinical interest for Actinium-225 labeled molecules increases, questions regarding future availability of industrial-scale quantities of this isotope cast doubt on the marketing viability of 225Ac-labeled drugs. 🔍 Explore further into this topic with our president & founder Richard Zimmermann's article: https://buff.ly/44nEqLE Would you like to see this and more exclusive articles? Access the latest edition of Radiotheranostics Today - https://buff.ly/3PYq9iB
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🌟 Exciting News! 🌟 I’m thrilled to share that my review article, "Challenges and Recent Advances in Erythropoietin Stability," has been accepted and published in Pharmaceutical Development and Technology. This paper explores the critical role of erythropoietin (EPO) in red blood cell production and the challenges faced in maintaining its stability for therapeutic efficacy. With the development of recombinant human EPO (rh-EPO) revolutionizing anemia treatment, the article addresses key issues surrounding EPO’s stability—such as degradation and loss of biological activity—and the latest advancements in formulation, including stabilizing agents, novel delivery systems, and storage techniques. I am particularly delighted to have co-authored this work with my former master's supervisor, Alaa Eldeen B. Yassin. This also marks the beginning of a productive collaboration with Professor Shanshan Luo from Huazhong University of Science and Technology, which will soon result in more papers in the coming weeks. https://lnkd.in/dDADa5a2 #research #pharmaceuticaldevelopment #EPO #collaboration #innovation
Challenges and recent advances in erythropoietin stability
tandfonline.com
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Senior Business Development professional | Technical Sales | R&D | Product Service, Marketing, Product Development | Ashland, Unichem Labs, Ipca Labs, ICMR
Product life cycle management (PLCM) is one the biggest symposium of Japan pharma where scientists from Pharma Industry including innovators, generics and OTC as well as researchers from academia along with pharma excipient manufacturers and pharma equipment manufacturers participate under one roof. Around 200 professionals gathered in person, after few years’ challenging circumstances under COVID-19, to the 17th PLCM symposium held at Meijo University in Nagoya, Japan. The symposium is an annual event initiated and coordinated by Professor emeritus Dr. Hisakazu Sunada and team at Meijo University in Nagoya, Japan. It was an excitement opportunity to be a part of this symposium as an industry speaker and receive an honor award for lecture from organizers. As an Ashland solver I talked on “Recent advances in excipients to formulate lower cost high performance ODT” and shared solution to high quality smaller size ODT formulations with lower manufacturing cost which troubleshoots the problem of dysphagia and hence it is a good choice for pediatric and geriatric patients. Yuji Shimizu-san, Country Sales Director Lifesciences Japan, Ashland, translated my talk in Japanese. #ashland #klucel #polyplasdone #ec #hpc #ecd #always #solving #pharma #pharmaceutical #odt #plcm #symposium #meijo #university #nagoya #japan #india #formulation #small #size AshlandDKSHConnell Caldic Product Lifecycle Management Indian Pharmaceutical Alliance Pharmexcil (Pharmaceuticals Export Promotion Council of India)
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𝗽𝗛 𝗜𝗻𝗱𝗲𝗽𝗲𝗻𝗱𝗲𝗻𝘁 𝗕𝗶-𝗹𝗮𝘆𝗲𝗿 𝗦𝗲𝗹𝗳-𝗺𝗶𝗰𝗿𝗼𝗲𝗺𝘂𝗹𝘀𝗶𝗳𝘆𝗶𝗻𝗴 𝗧𝗮𝗯𝗹𝗲𝘁𝘀 (𝗦𝗠𝗘𝗧𝘀) 𝗼𝗳 𝗖𝗮𝗻𝗱𝗲𝘀𝗮𝗿𝘁𝗮𝗻 𝗖𝗶𝗹𝗲𝘅𝗲𝘁𝗶𝗹 𝘄𝗶𝘁𝗵 𝗙𝘂𝗷𝗶𝗰𝗮𝗹𝗶𝗻® 𝗮𝗻𝗱 𝗡𝗲𝘂𝘀𝗶𝗹𝗶𝗻® - See the next newsletter topic by Fuji Chemical Industries Co., Ltd. Fuji Chemical Industries USA, Inc An angiotensin II receptor antagonist is a prodrug which gets converted to active drug Candersartan during absorption from the gastrointestinal tract. The conventional CDC tablets have a significantly low bioavailability of approximately 14% after oral administration. Self-microemulsifying Drug delivery system (SMEDDS) approach is becoming a common practice to enhance oral bioavailability of poorly water soluble drugs. To produce tablets of SMEDDS and to have a desired dissolution profile is considered one of the most difficult tasks for a formulator. Through several publications and commercial products, Neusilin® and Fujicalin® have proved to be some of the best adsorbent carriers available in the industry today. https://lnkd.in/gf58ChTQ #SMEDDS #Fujicalin #Neusilin
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