In recent years, a growing number of pharmaceutical companies in China have either undergone or successfully passed major international certifications such as WHO, Australian, and EU standards. According to Yu Mingde, Executive Vice President of the China Pharmaceutical Enterprise Management Association, around 20 companies are expected to have obtained these certifications this year. His confidence stems from both government policies and the industry's current momentum. The "11th Five-Year Development Guidance Opinions for the Pharmaceutical Industry" clearly states that China aims to secure listing qualifications for five pharmaceutical preparations in the U.S. or EU, with the goal of entering the global mainstream market. Currently, several companies have already made significant progress. Zhejiang Huahai became the first Chinese pharmaceutical company to pass the U.S. FDA certification, while Shenzhen Lijian has successfully exported cephalosporin preparations to Europe on a large scale. Other pioneers like Shanghai Tianping, Fosun Pharmaceutical, Xi'an Qianhe, and Dalian Meiluo are also making strides in exporting solid dosage forms. Even smaller enterprises, such as Shenzhen Gaozhuo, are actively preparing to enter the international market. “The desire of local companies to reach the global stage has never been stronger,” Yu said with conviction. The appeal of going global is evident. According to customs data, China’s export of Western medicines grew rapidly in 2007, reaching $784 million—a 55.68% increase compared to the previous year. However, most of these exports still come from foreign-funded enterprises, which dominate markets in Japan, South Korea, and Australia through processing trade. Domestic companies, on the other hand, mainly target lower-end markets in Africa and Asia. Due to limited R&D capabilities and a focus on generic products, many domestic firms struggle to penetrate the high-value European and U.S. markets. Yu Mingde points out that the U.S., EU, and Japanese markets account for 88% of the global pharmaceutical industry, offering significantly higher profit margins—up to 5 to 8 times that of the domestic market. With nearly half of China’s production capacity idle, the pressure to expand internationally has never been greater. The push to go global is now a shared industry goal. Dalian Meiluo Pharmaceutical, for example, was among the first to obtain the Australian TGA certification and has since secured OEM orders from the U.S., Germany, and the UK. Its production of solid formulations is set to increase to 3 billion tablets annually. Meanwhile, its ANDA application in the U.S. may soon be approved. According to Yu, China’s pharmaceutical sector has made great strides in closing the gap with global standards. Improvements in R&D, quality control (GMP, GCP, GLP, GSP), and compliance have brought Chinese manufacturers closer to international expectations. “The time is right for Chinese formulations to go global,” he said. Among the early adopters are companies like Shenzhen Lijian and Zhejiang Rishengchang. Shenzhen Lijian passed German cGMP certification in 2006, enabling it to enter the EU market. Similarly, Zhejiang Rishengchang achieved FDA approval for its compound polymyxin B ointment, becoming the first Chinese company to do so. These success stories highlight the importance of choosing the right international partners. While some companies opt for joint ventures or acquisitions, others prefer OEM partnerships. As Yu noted, finding a reliable local partner can be the easiest way to navigate complex regulatory environments. Companies like Hisun Pharmaceutical and Wuxi Kaifu have used this strategy effectively. However, challenges remain. International certification is not just about meeting technical standards—it also involves understanding cultural differences, regulatory procedures, and business practices. For many Chinese firms, this means building long-term relationships and gaining deeper market knowledge. Looking ahead, the trend of Chinese pharmaceuticals going global is likely to continue. As more companies meet international standards, they will gain access to higher-margin markets. While initial profits may be modest, the long-term potential is substantial. The key lies in strategic planning, quality control, and a deep understanding of the global market.

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