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In recent years, a growing number of Chinese pharmaceutical companies have either undergone or successfully passed major international certifications such as WHO, Australian TGA, and EU GMP. According to Yu Mingde, Executive Vice President of the China Pharmaceutical Enterprise Management Association, around 20 companies have achieved these certifications this year. His confidence stems from supportive government policies and the industry's evolving landscape. The "11th Five-Year Development Guidance Opinions for the Pharmaceutical Industry" clearly emphasizes the goal of obtaining U.S. or EU approval for five pharmaceutical preparations, aiming to enter the global mainstream market.
Zhejiang Huahai Pharmaceutical became the first Chinese company to pass the U.S. FDA certification, while Shenzhen Lijian has successfully exported cephalosporin preparations to Europe in large volumes. Companies like Shanghai Tianping, Fosun Pharmaceutical, and Xi'an Qianhe are also leading in the export of solid dosage forms. Even smaller firms, such as Shenzhen Gaozhuo, are actively preparing to access international markets, showing an unprecedented desire among domestic enterprises to reach global standards.
According to customs data, in 2007, the export value of Western medicines in China reached $784 million, reflecting a rapid growth rate of 55.68%. However, most of these exports come from foreign-funded enterprises, which primarily operate through processing trade. Domestic companies, on the other hand, mainly target lower-end markets such as Nigeria and Pakistan. This is due to limited R&D capabilities and the fact that many products are generic.
Yu Mingde highlights that the European, U.S., and Japanese markets account for 88% of the global pharmaceutical market, offering significantly higher profit margins—up to five to eight times that of the domestic market. With nearly half of domestic production capacity idle, the pressure to expand into international markets is mounting.
The push to go global is not just a trend but a strategic necessity. For example, Dalian Meiluo Pharmaceutical, after passing the Australian TGA certification, secured several OEM orders, including antipyretic tablets for the U.S. and Ginkgo biloba extracts for Germany. The company is also working on an ANDA application with the FDA, which could be approved by the end of the year.
Yu Mingde believes that China’s pharmaceutical sector has made significant progress in narrowing the gap with global standards. Improvements in R&D, GMP compliance, and quality control have brought Chinese products closer to international expectations. He sees this as the right time for Chinese formulations to break into the global market.
Among the pioneers, Shenzhen Lijian and Zhejiang Rishengchang stand out. Lijian obtained German cGMP certification, enabling it to enter the EU market through local partnerships. Rishengchang, after passing FDA certification, became the first Chinese company to export compound polymyxin B ointment to the U.S., marking a major milestone.
For Chinese companies, entering the international market requires more than just product quality—it demands understanding of foreign regulations, finding reliable partners, and building long-term strategies. As the industry continues to evolve, those who can navigate these challenges will lead the way in global expansion.