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Borui Pharmaceutical passed the US FDA cGMP on-site inspection

  • Categories:NEW
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  • Time of issue:2016-03-31 01:54
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Borui Pharmaceutical passed the US FDA cGMP on-site inspection

(Summary description)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.

  • Categories:NEW
  • Author:
  • Origin:
  • Time of issue:2016-03-31 01:54
  • Views:0
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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 the European and American regulatory markets It is predicted that the market after listing will exceed 100 million US dollars.

The quality system is an important basis for opening up the international market. Since 2010, Brilliant Bio has stepped on a step-by-step basis, steadily picked up the ranks, and continuously accumulated heights, reaching one milestone after another:

In 2012, all the raw materials of Xintai Pharmaceutical and Construction of preparation workshop.

In 2013, it passed the USFDA intermediate cGMP on-site inspection to assist TEVA in successfully challenging patents. Entecavir was first listed in the United States.

In 2015, caspofungin acetate passed the cGMP on-site inspection of EU medicines and obtained the EU cGMP certificate.

In 2015, Entecavir passed the GMP on-site inspection of the Chinese CFDA and obtained the Chinese GMP certificate.

In 2016, Fidaxine passed the USFDA's cGMP on-site inspection and passed the US cGMP certification.

Relying on the support of the internationally-aligned system and the high-tech barrier product line, the company's international expansion has flourished. In 2015, sales revenue increased by 50% year-on-year, and exports accounted for more than 70%, more than half of which came from European and American regulatory markets. With the advancement of time, the products in the early stage gradually entered commercialization, which provided a guarantee for the company's rapid development in the next five years.

While consolidating the foundation of industrialization, Borui Pharmaceuticals , which is “R & D-driven and continuous innovation”, also actively builds an innovative drug technology platform for anti-tumor, diabetes and liver disease in the research and development field. Beginning in 2016, a batch of innovative drugs with global competitive advantages will be successively applied for clinical trials, adding new impetus to the company's development.

 

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Borui Medicine

address:

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

Borui Medicine

phone:

0512-62620988

 

Borui Medicine

Fax:
0512-62551799

Copyright: Brilliant Biomedical (Suzhou) Co., Ltd. Website: CE Dongli · Suzhou Su ICP No. 18,000,014           

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