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In recent years, many pharmaceutical companies in China have either undergone or successfully obtained a series of mainstream international certifications, such as WHO, Australian TGA, and EU GMP. According to Yu Mingde, Executive Vice President of the China Pharmaceutical Enterprise Management Association, this year alone, around 20 companies have managed to pass these international standards. This growing trend reflects the increasing ambition of local firms to expand their presence on the global stage.
The push for international expansion is supported by both government policy and industry development. The "11th Five-Year Development Guidance Opinions for the Pharmaceutical Industry" explicitly states that Chinese pharmaceutical companies should strive to obtain listing qualifications in the U.S. or EU markets. Several pioneers have already made significant progress: Zhejiang Huahai became the first Chinese company to pass FDA certification; Shenzhen Lijian has successfully exported cephalosporin preparations to Europe; and companies like Shanghai Tianping, Fosun Pharmaceutical, and Xi'an Qianhe are also making waves in the export of solid dosage forms.
Beyond large state-owned enterprises, smaller and medium-sized firms such as Shenzhen Gaozhuo are also preparing to enter the international market. “The desire of local companies to reach the global market has never been stronger,†Yu said with conviction.
According to customs data, China's exports of Western medicines grew rapidly in 2007, reaching $784 million, a 55.68% increase from the previous year. However, most of these exports come from foreign-funded enterprises, which mainly engage in processing trade. Domestic companies, on the other hand, often target lower-end markets in Africa and Asia due to limited R&D capabilities and generic product focus.
Yu pointed out that the top three markets—Europe, the U.S., and Japan—account for 88% of the global pharmaceutical market. In these regions, the profit margins for generic drugs can be 5 to 8 times higher than in China. With nearly half of domestic production capacity idle, the pressure to move abroad is mounting.
For companies like Dalian Meiluo Pharmaceutical, going global is not just a dream but a strategic move. After obtaining TGA certification in 2005, the company secured major OEM contracts, including antipyretic tablets for the U.S. and Ginkgo biloba extracts for Germany. With an expected production scale of 3 billion tablets per year, the company is well-positioned for future growth.
Yu believes that China’s pharmaceutical industry is now ready to take on the global stage. Advances in R&D, quality standards like GMP and GSP, and the narrowing gap between domestic and international practices all point to a new era of global competitiveness.
Among the early adopters, companies like Shenzhen Lijian and Zhejiang Rishengchang have taken bold steps. Lijian passed German cGMP certification, while Rishengchang became the first Chinese firm to get FDA approval for its compound polymyxin B ointment. These successes highlight the importance of finding reliable overseas partners and understanding the nuances of foreign regulations.
As more Chinese firms aim to enter the global market, the challenge lies in navigating regulatory differences, building brand recognition, and developing long-term strategies. While some companies still rely on OEM models, others are moving toward full-scale international operations, including mergers and acquisitions.
Looking ahead, the global pharmaceutical landscape offers vast opportunities. With cost efficiency, high-quality production, and growing international demand, Chinese companies are well-placed to compete. However, success will require not only compliance with international standards but also a deep understanding of foreign markets and a commitment to innovation and long-term planning.