How Chinese Formulation and API Manufacturers Can Successfully Enter and Sustain Growth in Global Markets

Jan 03, 2025 14:43 CST Updated 14:43

Amid the tide of globalization, Chinese pharmaceutical companies are ushering in unprecedented opportunities for development and challenges. With the support of national policies and growing market demand, China has becomeThe World's Second-Largest Consumer of Pharmaceuticals, and is gradually advancing toward becoming a global pharmaceutical powerhouse. However, in this process, ensuring drug quality and compliance with international standards has become a critical issue that every company seeking to expand into overseas markets must address. According to statistics from the China Chamber of Commerce for Import and Export of Medicines and Health Products, China’s total import and export trade volume of pharmaceutical products in the global market reached USD 97.755 billion in the first half of 2024, a year-on-year decrease of 1.87%. Of this, the import value amounted to USD 45.176 billion, representing a year-on-year decline of 5.93%;Export value: US$52.579 billion, a year-on-year increase of 1.91%. This signals that China’s pharmaceutical exports have returned to normalcy in the first half of this year, following a period of significant volatility. The specific performance by product and market is as follows:

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Conclusion:

1. Rapid growth in exports of chemical drugs, medical consumables, diagnostic equipment, and other products , indicating a further optimization of the product structure of China's pharmaceutical exports ，Contributed incremental growth to overall exports.

2. Rapid Recovery in the EU and US Markets , with increases of 3.8% and 5.2%, respectively , offsetting India, Sluggish Performance in the Japanese and South Korean Markets.

3. The trend of steady growth in the ASEAN market continues , the diversified market structure has further deepened.

4. Influenced by geopolitical, political, and military dynamics, as well as the reshoring of active pharmaceutical ingredient (API) manufacturing in Europe, the United States, and India,The global pharmaceutical industry chain is undergoing transformation, with market diversification and optimization of the export structure emerging as new drivers for the growth of China’s pharmaceutical exports.

Topic:

1. Faced with such a fiercely competitive domestic market, should we still dive in headfirst only to be overwhelmed by the tide?

2. Based on the above analysis, it is evident that expanding into overseas markets is a sound strategic choice.

3. What should we do in the face of this opportunity? What should we know?

As is well known, the FDA’s testing standards for drugs and active pharmaceutical ingredients (APIs) differ significantly from those of the CDE in many specific areas. As an agency widely recognized by numerous countries around the world, the FDA has established highly mature and comprehensive drug standards and review mechanisms. Many global pharmaceutical standardization organizations, such as the EMEA, WHO, and ICH, are aligning their standards with those of the FDA. Given that FDA approval is the sole pathway for accessing the U.S. market—the largest pharmaceutical market globally—understanding the FDA’s requirements and approval processes for new drugs and generics holds substantial practical significance and provides valuable guidance for pharmaceutical companies. Therefore,What Are the Key Differences Between the FDA and the CDE??

Take a simple example: regarding instrument requirements for the gel-clot method of bacterial endotoxin testing, the FDA mandates automatic audit trails for the methodology of test results. In the absence of an automatic audit trail, appropriate points will be deducted during the corresponding review scoring. Currently, among bacterial endotoxin gel-clot readers available worldwide, most rely on manual gel preparation and visual observation for data auditing. Therefore, whether a system can meet FDA requirements to earn additional points has become a key consideration in the bacterial endotoxin testing process.

There are many such examples, which will not be listed individually here.

To adapt to market changes and trends, stimulate demand among Chinese enterprises, and drive business diversification for domestic companies,Xi'an Pharmaceutical Association in Collaboration with Suzhou Danhuang Technology Co., Ltd.、Beijing Chengfeng Jihai Technology Co., Ltd., at2025Year3At the beginning of the month, inXi'an CityCo-hosted [Training on Quality Control and Testing Standards for Exporting Finished Pharmaceutical Products and Active Pharmaceutical Ingredients]. At that time, distinguished experts and enterprises well-versed in domestic and international requirements for drug research and development, testing, and regulatory submissions will be specially invited to share their extensive experience and case studies accumulated over the years. The relevant information regarding the upcoming [Training on Quality Control and Testing Standards for Finished Dosage Forms and Active Pharmaceutical Ingredients in Global Markets] is hereby announced as follows:

Training Objectives and Positioning

I. Subject

1. Focusing on Chinese pharmaceutical companies' overseas product expansion businessesQuality Control and Implementation

2. Focusing on Chinese pharmaceutical companies' overseas product expansion businessTesting Standards and Applications

3. Focus on Related Testing and Analytical InstrumentsPractical Applications and Effect Demonstrations

II. Positioning

1. Enhance the quality of domestically produced export pharmaceuticals

2. Leading or aligning with international testing standards and methodologies

3．Showcasing the Manufacturing Capabilities and Standards of Chinese "Chips"

Training Overview

Training Name:Training on Quality Control and Testing Standards for Exported Finished Dosage Forms and Active Pharmaceutical Ingredients

Training Time:March 11–12, 2025

Training Scale:100 people

Training Location:Xi'an Hotel, 2nd Floor, Yannian Pavilion

Organizer:Xi'an Pharmaceutical Association

Organizer:Suzhou Danhuang Technology Co., Ltd., Beijing Chengfeng Jihai Technology Co., Ltd.

Guest Lineup

(1) Shan Min, Secretary-General of the Xi'an Pharmaceutical Association

(2) Liu Haijing, Dean of Shaanxi Provincial Institute for Food and Drug Control

(3) Gao Guang, FDA Reviewer Stationed in China

(4) Li Zhanjun, Former Chief Pharmacist, Physical and Chemical Laboratory, National Institutes for Food and Drug Control

(5) Zhang Qiming, Former Chief Pharmacist, Chemical Drug Division, National Institutes for Food and Drug Control

(6) Gao Hua, Former Chief Pharmacist, Department of Pharmacology, National Institutes for Food and Drug Control

(7) Wei Shifeng, Ph.D. & Chairman, Beijing Luonuoqiangshi Pharmaceutical Technology R&D Center Co., Ltd.

(8) Expert Lecturer, Shandong Lukang Pharmaceutical Co., Ltd.

(9) Expert Lecturer, Zhanjiang Andus Biotechnology Co., Ltd.

(10) Zhao Haishan, General Manager, Tianjin Tianda Tianfa Technology Co., Ltd.

(11) Expert Lecturer, Xi’an Janssen Pharmaceutical Ltd.

Participating Companies from Previous Events

Shanghai Pharma New Asia Pharmaceutical, Suzhou MSD, Changchun Zhuoyi Biotechnology, Ningbo Tianheng Pharmaceutical, Huadong Medicine, Hebei Senlang Biotechnology, Zhejiang Hemukang, Zhejiang Aisen Pharmaceutical, Sichuan Kelun Pharmaceutical, Ningbo Meinuohua, Innovent Biologics, Yunnan Baiyao, Heze Pharmaceutical, Lukang Pharmaceutical, Qilu Pharmaceutical, Haisen Pharmaceutical, Zhejiang Saimo Pharmaceutical, Jimin Kexin Pharmaceutical, Zhejiang Conba Pharmaceutical, Changzhou Pharmaceutical, Hangzhou Zhuyangxin, Nanjing Baijingyu, Inner Mongolia Jingxin Pharmaceutical, Zhejiang Puli Pharmaceutical, Hongyuan Pharmaceutical, Cheezheng Pharmaceutical, Zhejiang Hisun Pharmaceutical, Lunan Pharmaceutical, Hanhui Pharmaceutical, Huahai Pharmaceutical, Changhai Pharmaceutical, Zhejiang Jutai Pharmaceutical, Zhejiang Nhwa Pharmaceutical, Novo Nordisk, Hualan Biological Engineering, Sansheng Mandi Pharmaceutical, Evershine Biotech, Shenzhou Pharmaceutical, Zhejiang Xianju Pharmaceutical, Sanjin Pharmaceutical, Zhejiang Zhenyuan Pharmaceutical, Salubris Pharmaceutical, Shanghai Squibb

To register, please scan the QR code below:

Planning and preparations for all regional stations across China in 2025 are underway. The confirmed cities include:Beijing, Suzhou, Fuzhou...Other sub-sites and specific times are being updated continuously...

For more details and inquiries:

Please contact:Ying Erjia

Tel:13439390341 (WeChat)

E-Mail：ying.ej@vcbeat.net