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Borui Bio hosted the second round of the 2015 CBD

CHBD May 2015 Special Session-Drug R & D Innovation and BD Strategy in the New Situation and Entering Borui Bio, was held on May 14 in Suzhou Industrial Park Nano Science and Technology Park. Companies to undertake.

Borui Bio passed EU GMP certification

In early April 2015, Borui ushered in the first EU GMP inspection in the history of development. The inspection objects were Borui Xintai and Borui Taixing. Borui team resisted the pressure, went all out, cooperated sincerely, and finally passed the on-site inspection. In early June, the inspectors issued the first EU GMP certificates for the Credit Suisse and Taixing plants. This signifies that Borui has a production quality management system that complies with EU GMP standards and a production quality management platform that complies with regulatory requirements, opening up the European and American markets for its products and laying a solid foundation for internationalization.

Borui participates in the 16th CPHI exhibition

On June 23, 2015, the three-day 16th "World Pharmaceutical Ingredients China Exhibition" (CPHI Exhibition) kicked off at the Shanghai International Expo Center. Borui Bio's sales department and BD department participated in this pharmaceutical event. This exhibition brings together more than 100,000 professional buyers and suppliers from around the world to capture global business opportunities and leading resources. The Borui team seized the opportunity. During the exhibition, they had business negotiations with Actavis, Mylan, Teva, Fosun, Harbin Medicine, Livzon and other well-known domestic and foreign pharmaceutical companies. Through this exhibition, Borui has obtained front-end market information and consolidated

The company Entecavir obtained the drug approval number and passed the on-site inspection of China's official drug GMP certification

From July 8th to 10th, 2015, a drug GMP certification inspection team composed of officials from the Jiangsu Provincial Bureau of Drug Administration conducted comprehensive and careful production of Xintai Pharmaceutical's five major lines and real-time dynamic production of Entecavir in accordance with China's current GMP requirements The inspection passed the on-site inspection more smoothly.

Xintai Pharmaceutical Entecavir API GMP Certificate

Xintai Pharmaceutical's Entecavir API project, a wholly-owned subsidiary of Borui, passed the cFDA on-site inspection in July 2015 and successfully obtained the China Pharmaceutical GMP Certificate on September 28, 2015.

Borui Bio participates in 2015 CPhI global exhibition

On October 13th, the three-day World Raw Materials Pharmaceutical Exhibition 2015 was grandly opened in the “Gate of Europe” in Madrid. Borui Bio attended the event together with exhibitors from all over the world. The Borui team cherished high-quality products and sincerity In the face of customers from all over the world, I wish Borui a brilliant future in this exhibition.

Borui Pharmaceutical passed the US FDA cGMP on-site inspection

Recently, Xintai Pharmaceutical (Suzhou) Co., Ltd., a wholly-owned subsidiary of Borui Biomedical (Suzhou) Co., Ltd., successfully passed the cGMP on-site inspection by the US FDA. The self-developed super antibiotic "Fidamycin" is not only allowed to enter the US market, it may win patent challenges, be the first to be marketed in the United States, and obtain the protection of the market exclusivity period; at present, Fidamycin is an exclusive product in European and American regulatory markets It is predicted that the market after listing will exceed 100 million US dollars.

Borui Pharmaceutical Entecavir's new technology won the highest award of the Pharmaceutical Society

On December 8, 2016, the China Pharmaceutical Conference was held at the Beijing Convention Center. The project "Industrial anti-hepatitis B entecavir industrial application and clinical innovation research" project won the first prize of the 11th Chinese Pharmaceutical Association Science and Technology Award.

Borui Pharmaceutical successfully passed the certification of intellectual property management system

At the end of the year, Borui Biomedical (Suzhou) Co., Ltd. was awarded the "Intellectual Property Management System Certification" issued by China Standards (Beijing) Certification Co., Ltd.

Borui Medicine passed the Japanese PMDA official certification

On February 6, 2017, Xintai Pharmaceutical (Suzhou) Co., Ltd. and Borui Biomedical Taixing City Co., Ltd., two wholly-owned subsidiaries of Borui Biomedical (Suzhou) Co., Ltd., both successfully passed the Japanese GMP inspection of PMDA. . This result not only shows that Borui has mastered the operation procedures of MF declaration and data maintenance, but also marks that Borui's GMP level has reached the official requirements of Japan, which is well-known for its strict supervision, and has laid a solid foundation for Borui to enter the Japanese market. This is another step in the development of the international market after Borui Pharmaceutical successfully passed the official GMP certification in Europe and the United States.
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Borui Medicine


Building C25-28, 218 Xinghu Road, Suzhou Industrial Park, Jiangsu Province, China

Borui Medicine




Borui Medicine


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