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【EXPERT Q&A】What are the certification requirements for WC?

Drugdu.com expert’s response: WC, fully known as Written Confirmation, is a requirement for non-EU countries exporting Active Pharmaceutical Ingredients (APIs) to the EU market. The certification requirements for WC can be elaborated from the following aspects: I. Certification Authority and Document Issuance The WC certification document is an official document issued by the pharmaceutical regulatory authority of the API-producing country. This document certifies that the exported APIs comply with the Good Manufacturing Practice (GMP) standards of the EU. II. Application Conditions and Prerequisites Prerequisites: Pharmaceutical GMP certification involves rigorous audits of a manufacturer’s quality management system, production processes, equipment, and personnel to ensure that the drugs produced meet the relevant quality and safety requirements of the EU. Only enterprises that have passed GMP certification can obtain WC documents to export APIs to the EU market. Application Conditions: These typically include production licenses, descriptions of the quality management system, product details, ...
- Source: drugdu
- 82
- October 18, 2024
Dano Pharmaceuticals announces over 300 million RMB E-round financing to accelerate the late stage clinical development and commercialization of core new drug products | Aurora Family

Danuo Pharmaceutical On October 16, 2024, Danno Pharmaceutical, an investment company of Aurora Borealis, announced the completion of the first batch of delivery for over 300 million RMB in Series E financing. This round of financing is jointly led by Zhongshan Venture Capital and AMR Action Fund, a subsidiary of Zhongshan Investment Holdings. The funds obtained will be used to support the core new drug research and development pipeline, including the late stage clinical trials and commercialization of TNP-2198, a new drug candidate for treating Helicobacter pylori infection, and TNP-2092, a new drug candidate for treating implanted medical device infection. Dr. Ma Zhenkun, founder, chairman, and CEO of Danno Pharmaceuticals, said: We are delighted to receive support from Zhongshan Venture Capital and AMR Fund. Danno Pharmaceuticals is committed to addressing the dual challenges of bacterial resistance and tolerance, providing solutions for bacterial infections and metabolic related diseases that still lack ...
- Source: drugdu
- 69
- October 17, 2024
IPHASE ABC family P-gp transporter membrane vesicles have been successfully developed!

P-glycoprotein (P-gp) belongs to the ATP Binding Cassette (ABC) protein family and is an ATP dependent transmembrane efflux transporter. It is mainly encoded by the multidrug resistance gene (MDR1), also known as ABCB1 gene, in the human body. P-gp is related to multidrug resistance and drug drug interactions (DDIs). Drug regulatory authorities in the United States, Europe, and China have successively issued guidance principles, listing transporter mediated DDI research as an important indicator for evaluating the safety and efficacy of new drugs. It is also explicitly stated that in vitro studies should be conducted to evaluate whether the investigational drug is a substrate, inhibitor, or inducer of P-gp, providing reference for in vivo studies. Based on the above requirements, IPHASE/Huizhi and Yuanji have successfully constructed SLC transporter cells, including OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, and MATE2-K. In addition, they have also successfully constructed the first P-gp transporter membrane vesicle ...
- Source: drugdu
- 58
- October 17, 2024
Hengrui Medicine’s PD-1 combination therapy is re-registered for listing in the United States

On October 15, Hengrui Medicine issued an announcement announcing that it had received a “confirmation letter” from the FDA, and the resubmitted PD-1 monoclonal antibody carrelizumab injection combined with apatinib mesylate tablets for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma The biologics license application (hereinafter referred to as “BLA”) was accepted by the FDA. According to the Prescription Drug User Fee Act (PDUFA), the FDA’s target review date for carrelizumab injection is March 23, 2025. In October 2023, Hengrui Medicine reached a licensing agreement with Elevar Therapeutics, granting the latter exclusive rights to develop and commercialize carrelizumab liver cancer combination therapy worldwide, excluding Greater China and South Korea. In May this year, HLB-LS, the parent company of Elevar Therapeutics, announced that it had received a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for carrelizumab combined with apatinib for the first-line ...
- Source: drugdu
- 63
- October 17, 2024
3.7 billion blockbuster antihypertensive drug, Shandong New Era approved for listing!

Yesterday (October 14), the official website of the National Medical Products Administration (NMPA) announced that the Sacubitril Valsartan Sodium Tablets submitted by Shandong New Era Pharmaceuticals were approved and passed the review. Sacubitril Valsartan Sodium Tablets is an antihypertensive drug used for adult patients with chronic heart failure with reduced ejection fraction. As the world’s first breakthrough innovative drug in the field of heart failure treatment, Sacubitril Valsartan Sodium Tablets entered the Chinese market in 2017 for the treatment of heart failure, and was later included in the 2020 National Medical Insurance Catalogue. In June 2021, it was first approved in China for the treatment of essential hypertension. In 2021, in-hospital sales exceeded 2 billion yuan in one fell swoop, a year-on-year increase of 170%. According to the Zhongkang Kaisi system, the sales of hypertension drugs in graded hospitals in 2023 will reach about 24.2 billion yuan. In the subdivided ...
- Source: drugdu
- 68
- October 17, 2024
Another “hundred-ton” synthetic biology production line was successfully delivered, 60 million yuan!

On September 23, the food additive synthetic biology production line project of the biotechnology company undertaken by Sanxi Group successfully completed all installation and commissioning work and was delivered on schedule, which marked that the project has fully entered the production and operation stage. It is reported that the total investment of the production line is about 60 million yuan, and it is equipped with 4 fully automatic precision fermentation production lines. These production lines are equipped with advanced automated separation and purification systems, which can monitor various key parameters in the production process in real time to ensure comprehensive, efficient and precise control of product quality. The successful delivery of this project not only demonstrates Sanxi Group’s deep technical accumulation in the field of synthetic biology equipment manufacturing, but also reflects its efficient project management and delivery capabilities. In recent years, with the continuous development of technologies such as ...
- Source: drugdu
- 58
- October 17, 2024
MEDICA

Organiser：MEDICA Time：November 11 – 14, 2024 Address：Ostfach 10 10 06, D-40001 Düsseldorf; Stockum Church Street 61, D-40474, Düsseldorf, Germany Exhibition hall：Düsseldorf Exhibition Center Product range: Medical Equipment: Medical electronic instruments, ultrasound equipment, X-ray devices, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, hemodialysis equipment, respiratory equipment, hospital ward and operating room equipment, emergency room equipment, hospital office equipment, laboratory equipment, etc. Disposable Supplies: Disposable medical supplies, dressings and hygienic materials, various surgical instruments, etc. Medical Devices: Healthcare devices, home healthcare products, physiotherapy, plastic surgery techniques, etc. Medical Peripherals: Information and communication technology, medical services, publications, etc. About Africa Health： The MEDICA exhibition in Düsseldorf, Germany, is the largest and most authoritative trade show for hospitals and medical equipment worldwide, ranking first among medical trade exhibitions due to its unparalleled scale and influence. Held annually in Düsseldorf, Germany, MEDICA showcases a wide range of products and ...
- Source: drugdu
- 88
- October 17, 2024
Partners with 10 Indian AI Startups

Novo Nordisk recently partnered with 10 Indian artificial intelligence (AI) startups, marking an important moment for the Indian AI ecosystem. The Danish company, best known for its weight loss drug Wegovy, is leveraging AI innovations to streamline operations and improve efficiency. The moves are part of the Danish drugmaker’s expansion plans for operations in Bangalore, which it opened 17 years ago. The center helps manage the vast amounts of data collected about the safety and effectiveness of its drugs, including clinical trial information and reports of potential side effects. One of the factors driving the move is that demand for obesity and diabetes-related drugs is expected to grow, especially as global attention to these health issues grows. By strategically positioning itself in India, one of the world’s largest markets for diabetes drugs, Novo Nordisk expects to meet the growing demand by increasing its production capacity. The partnership also has a ...
- Source: drugdu
- 64
- October 17, 2024
【EXPERT Q&A】What certification is required for drug export to Vietnam?

Drugdu.com expert’s response: Exporting pharmaceutical products to Vietnam requires a series of certifications to ensure compliance with Vietnamese regulations and legal sale in the Vietnamese market. Here are the primary certification requirements: Ⅰ. Free Sales Certificate (FSC) from the Drug Regulatory Authority and Vietnam Embassy Authentication Free Sales Certificate (FSC) from the Drug Regulatory Authority: Definition: The Free Sales Certificate, also known as the Export Sales Certificate, is an official document issued by the drug regulatory authority, certifying that a particular pharmaceutical product or medical device meets relevant national standards and directives, allowing its free sale within the country and export to other countries. Role: In international trade, the FSC is a crucial document for enhancing a product’s international competitiveness, particularly when exporting to overseas markets like Vietnam, where it validates the legality and quality of the pharmaceutical products. Vietnam Embassy Authentication: Definition: Vietnam Embassy Authentication is an official certification ...
- Source: drugdu
- 73
- October 16, 2024
Collaborating with 10 Indian AI startups

These measures are part of the business expansion plan launched by this Danish pharmaceutical company in Bangalore 17 years ago. The center helps manage a large amount of data collected regarding the safety and efficacy of its drugs, including clinical trial information and potential side effect reports. One of the factors driving this initiative is that the demand for obesity and diabetes related drugs is expected to grow, especially with the increasing global attention to these health problems. Through strategic positioning in India (one of the world’s largest diabetes drug markets), Novo Nordisk is expected to meet the growing demand by improving its production capacity. This partnership has also had a broader impact on the operations of Novo Nordisk. It is expected that Novo Nordisk’s Bangalore center will become an approximate mirror of its Danish headquarters within three years. The company plans to increase the number of employees in Bangalore ...
- Source: drugdu
- 60
- October 16, 2024

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