Hefei Tianrui Pharmaceutical Chemical Co., Ltd. is located in the Industrial Park of Huagang Town, Feixi County, Hefei City. With excellent R&D capabilities, a complete set of complementary industrialization support, and an international CGMP quality management system, Tianrui is committed to providing professional technical services and commercialization of small molecule specialty APIs, CGMP standard intermediates, functional pharmaceutical excipients, and MRNA vaccine vectors for domestic and overseas well-known pharmaceutical enterprises.
  The company has independently developed and commercialized a range of new drug products, including Roflumilast, Rivaroxaban, Ezetimibe, Dasatinib, Repaglinide, Prucalopride Succinate, Salcaprozate sodium (8-(2-hydroxybenzamido)octanoate), Vandetanib, Garenoxacin, Ropinirole hydrochloride, Conivaptan hydrochloride, Crizotinib, Olaparib, Macitentan, Difamilast, Tepotinib, Tanimilast, Foscarbidopa, etc. Among them, Salcaprozate sodium (8-(2-hydroxybenzamido)octanoate) has successfully obtained registration numbers from both the Chinese CDE and the US FDA (CDE registration number: F20220000072; USDMF number: 037135).
  Meanwhile, we also have strength of long chain intermediates such as 8-Bromooctanoic Acid, 8-Aminooctanoic Acid, Methyl 8-bromooctanoate, Ethyl 8-bromooctanoate, 6-Bromohexanoic Acid, Ethyl 7-bromooctanoate, Diphenyl Phosphate, Tetrabenzyl pyrophosphate, 4-(Boc-Amino)cyclohexanone, etc.
  The products are mainly exported to Europe, North America, India, Japan, Korea and other countries, and we can provide the documentation support and audit requirements of the said corresponding regulatory markets.
  Tianrui Pharmaceutical is dedicated to the lifelong mission of striving for human health, continuously updating excellent products and services, and making contributions to breaking through the global barriers in the pharmaceutical industry.



 



In 2015, the company developed polypeptide absorbent permeation enhancers: ethyl 8-bromo-octanoate and carsalam, which is the 1st and only qualified Chinese supplier of semaglutide to meet the internal control requirements of innovator Novo Nordisk.



In 2020, the company independently developed and optimized 8-bromo-octanoic acid and 6-bromo-caproic acid to become a COVID-19 vaccine carrier manufacturer and supplier to Moderna company, contributing its share to the fight against COVID-19.




In 2022, Tianrui R&D Center and cGMP manufacturing facility was inaugurated and put into operation. And in the same year, polypeptide absorbent permeation enhancers SNAC (Salcaprozate Sodium) has successfully obtained the domestic CDE registration number (F20220000072) and the US FDA registration number (037135), and another batch of innovative APIs and pharmaceutical excipients are under registration and approval.


Tianrui pharmaceutical spirit of "quality first, integrity-based, customer first" business philosophy, sincerely welcome domestic and foreign clients to visit the factory and cooperation.





  

  APIs
  Vandetanib
  Roflumilast
  Garenoxacin
  Difamilast
  Macitentan
  Olaparib
  Ropinirole hydrochloride
  Crizotinib


  Pharmaceutical excipients
  SNAC(Salcaprozate Sodium)
  CDE registration number (F20220000072)
  FDA registration number (037135)


  mRNA
  8-Bromooctanoic acid
  9-Heptadecanol
  6-Bromohexanoic acid




 

  1.CDMO/CMO for APIs、Pharmaceutical excipients
  2.Route synthesis development and design for New product
  3.Development and optimization of API process
  4.Development and validation of analytical methods for API
  5.Processing and production of API
  6.Application registration and production review of API and pharmaceutical excipients