Recently, Hengrui Pharmaceuticals has received the GMP certificate issued by Japan Pharmaceuticals and Medical Devices Agency (PMDA) for its preparation production site located at No. 38, Huanghe Road, Lianyungang, and the company’s Dexmedetomidine Hydrochloride Injection has successfully passed the GMP compliance inspection by PMDA. This is the company’s quality management system again recognized by international authoritative institutions after the API dexmedetomidine hydrochloride PMDA site inspection was passed, which is conducive to the company to further strengthen the internationalization strategy and enhance the competitiveness in the global market. Japanese GMP certification is one of the authoritative certifications in the field of international drug production, and the inspection is characterized by rigor, meticulousness and attention to details.2023 In September, two qualification inspectors of Japan PMDA conducted a GMP on-site inspection for several days on Hengrui Pharmaceuticals’ Dexmedetomidine Hydrochloride Injection production line at the preparation production site located at No. 38 Huanghe Road, ...
Drugdu.com expert’s response: The Indonesian SAS, SNI, and LS certifications are different certification systems in Indonesia that cater to various industries and product types. Below is a detailed introduction to each: Ⅰ. Indonesian SAS Certification 1.Definition and Background: The SAS certification is a “Special Access Scheme” established by the Indonesian government in response to emergencies such as the COVID-19 pandemic. It allows the government to directly import urgently needed medical devices without first obtaining an import distribution license. This policy was announced by the Indonesian Ministry of Health through its official website, aiming to expedite the registration and approval process for critical medical equipment during emergencies such as pandemics. 2.Applicable Products: The SAS certification primarily targets medical devices that are urgently needed in Indonesia, including surgical gowns (including masks, personal protective equipment, medical goggles), liquid chemical disinfectants (including disinfectants, hand sanitizers), surgical gloves, patient examination gloves, clinical electronic thermometers, respirators, etc. 3.Application ...
Organiser:Nuremberg Exhibition Co. LTD Time:June 10th – 12th, 2025 address:Centro de Exposições Imigrantes, Rodovia dos Imigrantes, Km 1,5 São Paulo – SP Exhibition hall:São Paulo Expo Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Antipyretics and Analgesics, Medicines for Digestive System, Anti-infective Drugs, Antiparasitic Drugs, Cardiovascular Drugs, Intermediates Medical Devices: Pharmaceutical Packaging Materials, PVC/PVDC Laminates, PVC Rigid Sheets, PS Sheets, Packaging Anti-counterfeiting Technology Information, Labeling and Sleeve Labeling Technology, LabelFilling Machines, Packaging Container Forming, Filling, and Sealing Machines, Wrapping Machines, Paper Film Packaging Machinery, etc. Others: Large Infusion Equipment Production Lines, Dryers, Water Treatment Equipment, Refrigeration Compressors, Distillation Equipment, Sterilization Equipment, Tablet Presses, Coating Machines, Plastic Processing Equipment, Crystallization Equipment, etc. About FCE Pharma: FCE Pharma – the International Pharmaceutical Ingredients and Pharmaceutical Exhibition in São Paulo, Brazil, is the premier pharmaceutical technology exhibition in South America. It plays a pivotal role in the development of the pharmaceutical ...
Annually, sepsis claims the lives of 11 million people globally, with 1.3 million of these deaths linked to antibiotic-resistant bacteria. For clinicians, the ability to quickly and accurately interpret antimicrobial susceptibility testing (AST) results is essential to save lives and tailor treatment strategies effectively. Rapid AST not only improves patient outcomes but also reduces the global antimicrobial resistance (AMR) burden by supporting the execution of effective Antimicrobial Stewardship (AMS) programs. Predicting AMR in patients with gram-negative infections is often a more complex and time-consuming process. Early diagnosis and timely treatment are crucial in enhancing outcomes for sepsis patients. Studies have shown that each hour’s delay in administering antibiotics significantly increases the likelihood of hospital mortality, even if antibiotics are given within the first six hours. Now, a novel AST system delivers actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours, enabling same-day treatment ...
Organiser: Informa Exhibitions Group Time:January 22-23, 2025 address:1, place de la Porte de Versailles, 75015 Paris, France Exhibition hall:Paris Expo Porte de Versailles Product range: Ⅰ. Design and innovation of drug delivery systems, raw materials (aluminum, cardboard, plastic, and glass) Ⅱ. Transformers, packaging machinery, production equipment, automation and assembly line systems, product and packaging design services, parts and components for thermoforming packaging Ⅲ. Aerosols, ampoules, sprays, blisters, medical devices, pharmaceutical packaging, vials, unit doses Ⅳ. Labels and markings, medical pumps, medical bags, syringes, pen injectors, reconstitution systems, tubes, and more Ⅴ. Pharmaceutical subcontractors, printing and labeling, instruction manuals, brochures, sterilization technologies and services, control, tracking and anti-counterfeiting, transportation materials and services About Pharmapack: Pharmapack, the Pharmaceutical Packaging Exhibition in Paris, France, is the largest and most authoritative pharmaceutical packaging exhibition in the country. It brings together global leading industry designers, pharmaceutical manufacturers, drug packaging, and delivery system suppliers. It ...
The alarming rise of multi-drug-resistant (MDR) superbugs is a significant threat to global health, with traditional antibiotics losing their efficacy at an unprecedented rate. Antibiotic resistance is one of our time’s most pressing public health issues. It occurs when microbes evolve mechanisms to withstand the drugs designed to kill them, rendering standard treatments ineffective and leading to persistent infections and increased risk of spread. This phenomenon poses a significant threat to global health, development, and sustainability. Microorganisms can become resistant to antibiotics through genetic mutation, horizontal gene transfer, Efflux pumps and enzymatic degradation. Several factors contribute to the rise of antibiotic resistance. Amongst them, overuse and misuse of antibiotics is the most distressing. Prescribing antibiotics when they are not needed such as for viral infections and patients not completing their prescribed courses of antibiotics also contribute to the resistance. The use of antibiotics in livestock for growth promotion and disease ...
Shanghai, China, July 2, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world. Colorectal cancer (CRC) is one of the most common malignant cancers globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths were estimated in 2022, and the incidence rates were highest in Europe and Oceania [1]. It is estimated that, by 2040, the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and ...
The glucagon-like peptide 1 (GLP-1) receptor agonists have emerged as blockbuster drugs and have raked in billions in sales. However, the higher demand for these therapies has now led to multiple reports of shortages. In response to these events, the European Medicines Agency (EMA) has put forth recommendations to tackle the shortages of these GLP-1 receptor agonists like Eli Lilly’s Trulicity (dulaglutide), and Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Victoza (liraglutide). Another version of semaglutide, marketed as Wegovy, and Eli Lilly’s Mounjaro (tirzepatide) are approved in the EU for weight management in addition to diet and physical activity. The EMA has recommended that manufacturers and distributors avoid promotional activities for these products until the shortage persists. Cooke noted that EU member states should preserve stock, by controlling/limiting prescriptions. Broich stated that physicians should avoid prescribing GLP-1 receptor agonists for cosmetic use or in obese patients without any co-morbidities or ...
Organiser:Reed Sinopharm Exhibitions Time:October 12 – 15, 2024 address:No. 1 Zhancheng Road, Heping Community, Fuhai Street, Bao’an District, Shenzhen Exhibition hall:Shenzhen World Exhibition & Convention Center (New Hall) Product range: Medical Imaging Area: Radiology products, ultrasound products, nuclear medicine products, molecular imaging, interventional products, etc. Operating Room Area: Hybrid operating rooms, integrated operating room systems, surgical instruments, anesthesia machines, ventilators, monitors, operating room engineering, surgical lights, ceiling-mounted towers, etc. In Vitro Diagnostic Area: Overall laboratory solutions, clinical diagnostic equipment, diagnostic reagents, POCT, home diagnostic equipment, etc. Rehabilitation and Physiotherapy Area: Rehabilitation equipment, assistive devices, traditional Chinese medicine treatments, physical therapy equipment, medical high-frequency equipment, etc. Orthopedics Area: Orthopedic implants, surgical instruments and equipment, bone power tools, and other orthopedic-related products covering three main categories: joints, trauma, and spine. Medical Information Technology Area: System integrators, mobile healthcare, medical management, quality control, clinical hospital information management systems, IT equipment providers for ...
Dive Brief Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration. One product is the company’s Lingo device, sold as a wellness product for people who do not have diabetes. The other is Abbott’s new Libre Rio device, which is intended for adults with Type 2 diabetes who do not use insulin, posing a direct challenge to Dexcom’s Stelo device. After Lingo was cleared last week, RBC Capital Markets analyst Shagun Singh wrote the over-the-counter nod could offer a more than $1 billion sales opportunity for Abbott. Dive Insight Abbott had discussed plans to bring Lingo to the U.S. after releasing it in the U.K. last year. The device, which can be worn on the upper arm for 14 days, tracks glucose to help people understand how their bodies react to different foods, exercise and stressors. Abbott received FDA ...
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