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Borui Pharmaceutical passed the official KFDA certification of South Korea

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  • Time of issue:2017-09-22 14:49
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Borui Pharmaceutical passed the official KFDA certification of South Korea

(Summary description)Recently, Borui Biopharmaceutical (Suzhou) Co., Ltd. added another good news. Its wholly-owned subsidiary Xintai Pharmaceutical (Suzhou) Co., Ltd. passed the on-site assessment by the Korea Food and Drug Administration (KFDA) and obtained KFDA official certification. Entered the Korean market. This is another milestone for Borui Pharmaceutical to explore the international market.

  • Categories:NEW
  • Author:
  • Origin:
  • Time of issue:2017-09-22 14:49
  • Views:0
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Recently, Borui Biopharmaceutical (Suzhou) Co., Ltd. added another good news. Its wholly-owned subsidiary Xintai Pharmaceutical (Suzhou) Co., Ltd. passed the on-site assessment by the Korea Food and Drug Administration (KFDA) and obtained KFDA official certification. Entered the Korean market. This is another milestone for Borui Pharmaceutical to explore the international market.

 

Borui Pharmaceutical has successfully passed the official cGMP certification of Europe, the United States and Japan, established a complete management system in terms of production and quality management, formulated standardized operating procedures and an efficient feedback error correction mechanism. Officials in charge of on-site inspection at the KFDA in South Korea reviewed the written documents of the six GMP systems in detail, inspected the production situation and QC laboratory on site, retrieved the inspection records, and asked the production personnel and QC personnel about the SOPs in detail. Rui's quality system fully meets the KFDA official requirements.

 

In 2006, Borui Pharmaceutical developed the entecavir patent process, successfully supporting Jiangsu Zhengda Tianqing to obtain the first domestic imitation; in the United States, Teva challenged the entecavir patent, was first listed and successfully obtained a 180-day market exclusivity period. Brilliant medicine grace registered entecavir products in the United States, Europe, Japan, Canada, Australia, South Korea, India, Turkey, Russia, Southeast Asia, Middle East, Africa and other countries and regions, is entecavir products the world's largest supplier. With the expansion of Borui Medicine's internationalization, it will fill more gaps in the international market in the future, bringing more economical treatment options for chronic hepatitis B patients worldwide, and benefiting patients worldwide.

 

About Hepatitis B and Entecavir

Hepatitis B is an infectious disease caused by hepatitis B virus infection. Chronic hepatitis B can cause cirrhosis and liver cancer. Northeast Asia (outside Japan), Southeast Asia, and South Asia are regions with a high incidence of hepatitis B worldwide, with an incidence of 6-8%. China is a large country with hepatitis B, with 130 million people carrying the virus, accounting for half of the world, and 10 million people with chronic active hepatitis B. Chronic hepatitis B has been one of the most important public health issues in China and the world.

 

Entecavir is a new generation of oral guanine nucleoside analogs. It is also one of the drugs with the strongest anti-HBV activity and the lowest drug resistance rate. It is mainly used to treat adults with active virus replication and continuous increase of serum aminotransferase, or liver histology Chronic hepatitis B with active lesions. Entecavir is the first-line anti-HBV drug recommended by the United States, Europe, Asia-Pacific, and WHO, all the guidelines for the prevention and treatment of chronic hepatitis B.

 

About Korea Food and Drug Administration certification

South Korea is the world's top ten drug importer and one of the most developed drug markets in Asia. KFDA certification is a domestic product production and sales license issued by the Korea Food and Drug Administration (KFDA). Established in 1996, the Korea Food and Drug Administration (KFDA) is responsible for ensuring the safety of consumer products such as food and medicine, in order to ensure the health of citizens and support the development of the food and drug industry. Imported drugs that pass the inspection and quarantine will be allowed to import and issue import certificates. After the imported drugs enter the market, local FDA drug inspection agencies and local drug safety agencies will also conduct random inspections in the field of distribution.


 

 

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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

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