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International Registration, Double Happiness

  • Categories:NEW
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  • Time of issue:2018-11-30 14:35
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International Registration, Double Happiness

(Summary description)Recently, Borui Pharmaceuticals has double-happiness in the international registration: Yixi has submitted Entecavir CEP to the European Union, paving the way for the product to enter the European market; Erxi has submitted Entecavir tablets to the US FDA ANDA registration application, this is also the first ANDA application in the history of Borui Medicine.

  • Categories:NEW
  • Author:
  • Origin:
  • Time of issue:2018-11-30 14:35
  • Views:0
Information
1

Recently, Brilliant medicine on the international registration of a double celebration: a Joy Brilliant medicine to the EU submitted a Entecavir API CEP, for the products to enter the European market and prepared the way; two hi is Borui medicine submitted entecavir to the US FDA ANDA registration application, this is also the first ANDA application in the history of Borui Medicine .

Under the strategy of focusing on both internationalization and innovation, the international preparation market has also become one of the more and more important development drivers of Borui Medicine . Borui Pharmaceutical will open the way of overseas declaration through the application of Entecavir and take the first step in exporting preparations to Europe and the United States. With more CEP and ANDA approvals being obtained, the product line will continue to be enriched, laying a solid foundation for the sustainable and rapid development of the company. This indicates that after completing the vertical integration of the product industry chain and improving the production quality system, Borui Pharmaceuticals has accelerated the pace of international registration and created a global layout in the field of preparations, which is a milestone.

In 2006, Borui Pharmaceutical developed the patented entecavir process, breaking the monopoly of foreign companies, and successfully supporting Jiangsu Zhengda Tianqing to obtain the first domestic imitation; in the United States, it supported Teva to successfully challenge the patent, and the first imitation listing was granted a 180-day monopoly period. Brilliant medicine grace registered entecavir and intermediate 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 series of the world's largest supplier of , To bring more economical treatment options for chronic hepatitis B patients worldwide, benefiting patients worldwide.

 

About Entecavir

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 CEP

The Certification of Suitability to Monograph of European Pharmacopoeia was earlier referred to as COS, now called CEP, and was initiated by the European Medicines Quality Management Agency (EDQM) for APIs and excipients that have been included in the European Pharmacopoeia (EP). An independent quality evaluation program to prove that the quality of the drug substance and excipients is strictly controlled according to the method described in the monograph of the European Pharmacopoeia, and the product quality meets the European Pharmacopoeia standards.

CEP is the European Union's certification of the drug quality system, one of the highest threshold drug certifications in the world, and a pass for pharmaceuticals to enter the EU market. It is known as the "green card" for entering the European and American markets. CEP is not only recognized by all EU members, but also recognized by other countries that have signed bilateral agreements, such as Australia, Canada, etc.

 

About ANDA

Abbreviated New Drug Application (ANDA) is approved as the first step for generic drugs to enter the US market. Companies need to submit applications to the US FDA to prove the biologics of generic drugs and original drugs (also referred to as reference drugs). Effectiveness, generic drugs will be included in the list of approved drugs (or "orange book") after approval. The US FDA's evaluation standards have always been industry benchmarks, so the approval of ANDA is considered to be an important passport to knock on the door of the European and American markets and enter the world.

 

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