WHO prequalification: DONE!!!

The world's first dual crystal API supplier for the World Health Organization market

At 3:56 pm on June 9, 2025, Hebei Xingang Pharmaceutical Co., Ltd. ushered in a historic moment. The anti tuberculosis drug raw materials rifampicin (crystal form I) and rifampicin (crystal form II) produced by Hebei Xingang Pharmaceutical have passed the World Health Organization certification, becoming the world's first dual crystal API supplier in the WHO market. This milestone achievement not only marks a solid step for Xingang Pharmaceutical in the international pharmaceutical market, but also injects new vitality into the development of the biopharmaceutical industry in Zhao County.

Hebei Xingang Pharmaceutical Co., Ltd. is located in Zhao County Industrial Park, with a superior geographical location and convenient transportation. The company is mainly engaged in the research and development, production, and sales of rifampicin bio fermentation, pharmaceutical intermediates, and API series products. Since 1998, the company has been engaged in the research and development of anti tuberculosis drugs, focusing on the development of a series of anti tuberculosis APIs, and has gradually developed into a high-tech enterprise in the whole industrial chain, such as biological fermentation, purification of active ingredients, chemical synthesis, and finished preparations.

In recent years, the company has collaborated with multiple universities and research institutions to conduct extensive and bold experiments in technology, equipment, and strain selection through external recruitment and internal training, as well as delegated training. Significant breakthroughs have been made in fermentation strain selection, purification process optimization, and synthesis impurity control, with 4 invention patents and 8 utility model patents obtained. The company has also been awarded multiple provincial and municipal honorary titles such as Hebei Province High tech Enterprise and Specialized and Innovative Demonstration Enterprise. The successful certification by the World Health Organization means that Xingang Pharmaceutical's production facilities, quality management system, and products meet the highest international standards and have been recognized by the world's most authoritative health organization.

Zhao Jianqiang, General Manager of Hebei Xingang Pharmaceutical Co., Ltd., said: Obtaining the World Health Organization certification is the result of our years of hard work. This is not only a recognition of our product quality, but also a high affirmation of our overall strength and management level. The World Health Organization certification will open the door to the international market for the company, especially in developing countries. The recognition of the World Health Organization will greatly enhance the market competitiveness and credibility of the company's products. In addition, certification also means that Xingang Pharmaceutical will take on more international responsibilities and contribute to the global public health cause.

After passing the certification this time, Hebei Xingang Pharmaceutical will directly supply one-third of its total production capacity to the World Health Organization market, contributing the "Zhao County Power" to the global public health cause. This measure will effectively enhance the stability and accessibility of the global supply chain for anti tuberculosis drugs, especially in responding to public health emergencies by quickly providing high-quality drug support.

Looking ahead to the future, Xingang Pharmaceutical stated that it will take this World Health Organization certification as an opportunity to further expand production scale, improve product quality, strengthen international cooperation, and strive to become a leading domestic and world-class pharmaceutical industry base.