Suppliers / Jiangsu Hengrui Pharmaceuticals

Jiangsu Hengrui Pharmaceuticals

China 0BO.F Updated 9 July 2026

Jiangsu Hengrui Pharmaceuticals is an API manufacturer based in China. It holds 18 active US drug master files and 6 valid CEPs across a filed portfolio of 19 molecules. Its filings concentrate with US FDA, ARCSA (EC) and MINSA (CR). Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 4 April 2025 as VAI.

18
active US DMFs
6
valid CEPs
5
registered plants 2 with an FDA FEI number
15
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
7 of 7 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 4 April 2025 VAI US FDA
  • 19 January 2024 NAI US FDA
  • 13 April 2018 VAI US FDA
  • 28 August 2015 NAI US FDA
  • 10 September 2013 NAI US FDA
  • 20 August 2013 NAI US FDA
  • 1 August 2012 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Lianyugang, United Arab Emirates Not on file
JIANGSU, China Not on file
Lianyungang, China Not on file
China, China 3011603969
China, China 3006689263

What they file, and where

Molecule Regulators Docs
Oxaliplatin EDQM, SFDA (Saudi Arabia), US FDA 4
Etoposide EDQM, SFDA (Saudi Arabia), US FDA 3
Dexmedetomidine SFDA (Saudi Arabia), US FDA 2
Letrozole EDQM 2
Sevoflurane EDQM, US FDA 2
Bupivacaine US FDA 1
Carmustine US FDA 1
Caspofungin US FDA 1
Cyclophosphamide US FDA 1
Desflurane US FDA 1
Show all 19 molecules on file
Docetaxel US FDA 1
Fondaparinux US FDA 1
Gadobutrol US FDA 1
Gadoteric Acid US FDA 1
Ifosfamide US FDA 1
Iodixanol US FDA 1
Irinotecan US FDA 1
Rivoceranib US FDA 1
Tolvaptan US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 5 1
ARCSA (EC) 3 None
MINSA (CR) 2 None
JFDA (JO) 1 None
NCELS (KZ) 1 None
EDE (AE) 1 None
EMA None 7
ANVISA (Brazil) None 1

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Open risk flags

  • 4 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 4 April 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates