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Product is king, quality escort

  • Categories:NEW
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  • Time of issue:2018-11-20 14:37
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Product is king, quality escort

(Summary description)In mid-October 2018, the official inspection team of the European Union conducted cGMP on-site inspections at two production sites of Xintai Pharmaceutical and Boruitaixing, which are wholly-owned by Borui Pharmaceutical.

  • Categories:NEW
  • Author:
  • Origin:
  • Time of issue:2018-11-20 14:37
  • Views:0
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In mid-October 2018, the official inspection team of the European Union conducted cGMP on-site inspections at two production sites of Xintai Pharmaceutical and Boruitaixing, which are wholly-owned by Borui Pharmaceutical. The inspection lasted for 5 days, and inspected three products, caspofungin, micafenthrin, and anifenthrin, covering the entire production process of strains, fermentation, purification, and synthesis. Control and financial systems were inspected. The inspection team spoke highly of the GMP systems of the two companies at the summary meeting. Borui Pharmaceuticals has recently obtained cGMP certificates for caspofungin, micafungin and anifenjing issued by the European Union.

 

Borui Pharmaceutical passed the cGMP inspection of the European Union for the first time in 2016. After the expiry of the caspofungin compound patent in April 2017, Borui Pharm listed caspofungin injections in Germany, Britain, Italy, Spain and other countries. As Anifenvir has expired in March 2018, the compound patent will be invalidated in September 2020. This time, the successful acquisition of the EU cGMP certificate will not only ensure that Borui Pharmaceutical's Supply, and also obtained the permits of Anifenjing and Micafenjing to enter the EU market, opening up access for the European market.

 

Fenjing products are the first-line drugs for clinical treatment of deep fungal infections, and are often used in severe patients at the late stage of severe infection, organ transplantation, and tumor chemoradiotherapy. Because the effect is exact and safe to use, it continues to grow rapidly after being marketed. Because Fenjing products span multiple technical fields of fermentation, purification, and synthesis, there are many technical difficulties, complex production processes, and difficult quality control, and the market is relatively scarce.

 

Borui Pharmaceuticals, with its mission of continuous innovation, vigorously develops scarce product pipelines on the one hand and continues to strengthen its competitive advantages; on the other hand, according to international standards, it continuously invests for a long time and continuously improves its production and quality management system. From quality concept to quality management standards, it is in line with international standards, and continuously improves product competitiveness with excellent product quality.

 

Borui Pharmaceutical has obtained GMP certificates from the United States, the European Union, Japan, South Korea and China. At the end of 2017, "Zero Defect" passed the on-site inspection of the US FDA. The successful inspection of the European Union is not only a positive recognition of the company's excellent quality management system. It is also a recognition and praise of the professionalism and professionalism of the staff of the company.

 

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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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