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A Detailed Guide to EU API WC Certification

Navigating the export of Active Pharmaceutical Ingredients (APIs) to the European Union involves a critical component: obtaining the WC (Written Confirmation) certification. This certification is essential to assure that your product aligns with the EU's stringent quality and safety standards prior to market entry. In the competitive landscape of global pharmaceuticals, understanding the intricacies of WC certification is key to ensuring a seamless export process to the EU. Here, Drugdu.com, a specialized cross-border medical trade B2B platform, offers an in-depth interpretation of the EU API WC certification process, aimed at providing a clear understanding of its requirements, application procedure, and necessary documentation.
- Source: drugdu
- 219
- January 12, 2024
Discover the Advanced Medical Centrifuge Solutions from Hunan Kecheng Instrument Equipment Co., Ltd.

Hunan Kecheng Instrument Equipment Co., Ltd., a leading manufacturer of medical centrifuges, is delighted to showcase its extensive range of products, including high-speed centrifuges, low-speed centrifuges, refrigerated centrifuges, blood bank centrifuges, and more. Our centrifuges are designed to cater to the needs of hospital laboratories, medical laboratories, and beauty institutions worldwide. Understanding that choosing the right centrifuge can be challenging, our low-speed centrifuges are tailored for hospital laboratories, especially for vacuum blood collection tube separation. We offer a unique solution with an automatic uncapping feature post-centrifugation, enhancing efficiency and reducing manual effort. Our patented rotor design for automatic uncapping includes multiple capacities, catering to different hospital requirements. Our product line includes: TD4K blood card special centrifuge: Ideal for blood type serology, routine blood tests, and immunoassays. TD4B cell smear centrifuge: Extensively used in immune blood laboratories for red blood cell serology and antigen identification. 3-5N urine sediment centrifuge: A ...
- Source: drugdu
- 178
- December 15, 2023
CanSino Biologics completed the first subject enrollment in Phase I clinical trial of its component diphtheria-tetanus and pertussis combined vaccine for adolescents and adults

Recently, CanSino Biologics’ adsorbed acellular (component) diphtheria-tetanus combination vaccine (hereinafter referred to as “Tdcp for adolescents and adults”) officially launched Phase I clinical trials and completed the enrollment of the first subject. Tdcp for adolescents and adults is suitable for people aged 6 years and above. It is a booster vaccine for adolescents and adults. This randomized, blinded, controlled phase I clinical trial will initially evaluate the safety and immunogenicity of the vaccine. Whooping cough, diphtheria and tetanus, also known as diphtheria, are serious diseases caused by bacteria. Since the protective effect of immunity triggered by the main antigen of pertussis gradually decreases after vaccination, the incidence and mortality of pertussis gradually increase in the post-vaccination population. The domestic market is in urgent need of a DPT vaccine with longer-lasting immune protection and higher safety. Major developed countries have included this vaccine in their regular vaccination plans, but there is ...
- Source: drugdu
- 140
- December 14, 2023
Meet Drugdu.com at CPhI Barcelona 2023!

From October 24th to 26th, 2023, the world-renowned pharmaceutical trade show – CPhI Barcelona will once again open its doors to the elites of the global pharmaceutical industry. It’s a platform that showcases new technologies, advanced equipment, and innovative products. Drugdu.com – Your Trusted Partner As a global B2B online platform dedicated to the pharmaceutical industry, Drugdu.com will also be participating in this grand event. Our booth is located at Hall 2 / 2Y01. We warmly invite you to visit us. Why should you visit our booth? Global Exposure: Display your brand and products to a worldwide audience. Potential Business Opportunities: Explore and unlock collaboration opportunities with various potential buyers and suppliers. National Agent Recruitment: If you are a manufacturer looking for overseas agents or distributors, we can help you find the right partner. One-stop Digital Marketing: Learn how to promote your products and brand more effectively. Authoritative Industry Accreditation: ...
- Source: drugdu
- 263
- October 9, 2023
A Comprehensive Guide

Pharmaceutical businesses face a unique challenge: they must navigate a maze of strict industry standards when marketing their products, ensuring every step aligns with industry regulations and legal requirements. While these constraints can seem daunting, digital marketing holds vast potential for these enterprises, offering myriad channels and methods to craft compelling strategies that not only resonate with potential audiences but also remain compliant. Drugdu.com has summarized five digital marketing strategies specifically for the industry: 1.Gain Attention on Search Engines Using SEO Search Engine Optimization (SEO) is the cornerstone of any online digital marketing. It ensures your website or page appears in the search engine results, leading customers to you. As SEO can drive traffic to your website, it plays an indispensable role in pharmaceutical digital marketing. To stand out amongst numerous websites, optimization is key. How to achieve a good ranking in search engines? ① Optimize titles and tags ② Eye-catching ...
- Source: drugdu
- 385
- August 18, 2023
B2B Platforms Content Marketing Digital Marketing Pharmaceutical Companies Reputation Management SEO Social Media
Pukang Biotechnology Completes Phase IV Clinical Trial of Hepatitis A Vaccine

Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
- Source: drugdu
- 153
- July 20, 2023
New clues to why some people suppress HIV without drugs

Some HIV patients are naturally able to keep the virus fully in check without any medicinal help, a phenomenon that has intrigued scientists for decades. New research appears to identify at least one reason why: an abnormally powerful version of an infection-fighting white blood cell called CD8+ T cell. CD8+ T cell’s are a type of T cell, a normal feature in everyone’s immune system. T cells typically amass in the lymph nodes of an HIV-infected patient. But among “spontaneous controllers”—those with the rare ability to automatically corral HIV and prevent it from triggering illness—investigators found that CD8+ T cells appear significantly more adept at identifying and stopping HIV. “About one in 300 people are able to control HIV without the need for medications,” noted study author Dr. Bruce Walker, director of the Ragon Institute of MGH, MIT and Harvard, an immune system research center in Cambridge, Mass. It appears ...
- Source: drugdu
- 221
- May 24, 2023
Opzelura, Dermavant’s Vtama cream hits goal in eczema phase 3 study

Incyte’s Opzelura cream may be looking at a new competitive rival in the lucrative atopic dermatitis field. Wednesday, Dermavant Sciences said its topical drug Vtama has come out successful in the first of two phase 3 studies the company is running in atopic dermatitis. As William Blair analysts see it, Vtama’s results put it “in reach of Opzelura on efficacy,” although one important data point remains unknown. In a phase 3 trial called ADORING 2, 46.4% of eczema patients who received the Vtama cream enjoyed clear or almost clear skin at week 8 while demonstrating at least a two-grade improvement from baseline. Vtama’s skin clearance rate was higher than the 18% observed in control patients who got a dummy therapy. Vtama also aced other secondary endpoints. The topical AHR agonist helped 59.1% of patients experience a 75% reduction from baseline in the Eczema Area and Severity Index (EASI), versus 21.2% in the ...
- Source: drugdu
- 253
- March 16, 2023
Molecular component of caffeine may play a role in gut health

Brigham researchers studying how and why certain cell types proliferate in the gut found that xanthine, which is found in coffee, tea and chocolate, may play a role in Th17 differentiation. Insights may help investigators better understand gut health and the development of conditions such as inflammatory bowel disease. The gut is home to a cast of microbes that influence health and disease. Some types of microorganisms are thought to contribute to the development of inflammatory conditions, such as inflammatory bowel disease (IBD), but the exact cascade of events that leads from microbes to immune cells to disease remains mysterious. A new study by investigators from Brigham and Women’s Hospital explores exactly what leads to the generation of Th17 cells—an important subtype of cells in the intestine—and uncovers some of the underappreciated molecular players and events that lead to cell differentiation in the gut. One of those players is the purine metabolite xanthine, which is found ...
- Source: drugdu
- 277
- March 15, 2023
An overview of COVID-19-associated neurological complications in children

In a recent study posted to the Research Square* preprint server, an international team of researchers review current literature to understand the association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, abnormal neuroimaging manifestations, and neurological symptoms among individuals under the age of 18. Background The clinical presentation of the coronavirus disease 2019 (COVID-19) varies widely across individuals, ranging from asymptomatic or mild to severe cases involving acute respiratory distress syndrome (ARDS), pneumonia, and multi-organ complications. Emerging evidence suggests that the thrombogenic reactions and cytokine storm that develop during acute COVID-19 contribute to psychiatric and neurological complications, with a high incidence of intracerebral hemorrhage and ischemic stroke. While many studies have investigated the neurological complications associated with acute SARS-CoV-2 infections among adults, COVID-19 manifestations among children have largely been asymptomatic or mildly symptomatic and not require hospitalization. However, emerging evidence indicates that systemic symptoms such as secondary inflammatory responses, which are collectively known ...
- Source: drugdu
- 320
- March 15, 2023

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