Suppliers / Jiangsu Hengrui

Jiangsu Hengrui

China 0BO.F reconciled across 9 public records · 5 entities Updated 9 July 2026

Jiangsu Hengrui is an API and finished-dose manufacturer based in China. It holds 21 active US drug master files and 6 valid CEPs across a filed portfolio of 21 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.

21
active US DMFs
6
valid CEPs
10
registered plants 3 with an FDA FEI number
34
filings across 9 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
  • 25 October 2024 VAI US FDA
  • 19 January 2024 NAI US FDA
  • 20 July 2018 NAI US FDA
  • 13 April 2018 VAI US FDA
  • 28 August 2015 NAI US FDA
  • 27 March 2015 VAI US FDA
  • 10 September 2013 NAI US FDA
  • 6 September 2013 VAI 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
Shanghai, United Arab Emirates Not on file
Lianyungang, China Not on file
JIANGSU, China Not on file
Lianyungang, China Not on file
China, China 3011603969

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Oxaliplatin EDQM, SFDA (Saudi Arabia), US FDA 5
Etoposide EDQM, SFDA (Saudi Arabia), US FDA 3
Sevoflurane EDQM, SFDA (Saudi Arabia), US FDA 3
Dexmedetomidine SFDA (Saudi Arabia), US FDA 2
Docetaxel SFDA (Saudi Arabia), US FDA 2
Ifosfamide SFDA (Saudi Arabia), US FDA 2
Letrozole EDQM 2
Tolvaptan SFDA (Saudi Arabia), US FDA 2
Atracurium Besylate SFDA (Saudi Arabia) 1
Bupivacaine US FDA 1
Show all 21 molecules on file
Carmustine US FDA 1
Caspofungin US FDA 1
Cisatracurium SFDA (Saudi Arabia) 1
Cyclophosphamide US FDA 1
Desflurane US FDA 1
Fondaparinux US FDA 1
Gadobutrol US FDA 1
Gadoteric Acid US FDA 1
Iodixanol US FDA 1
Irinotecan US FDA 1
Rivoceranib US FDA 1

Also appears on these molecule pages

Bupivacaine API Carmustine API Caspofungin API Cyclophosphamide API Dexmedetomidine API Docetaxel API Etoposide API Fondaparinux API Gadobutrol API Gadoteric Acid API Icatibant finished dose Ifosfamide API
Show 6 more molecule pages
Iodixanol API Irinotecan API Letrozole API Oxaliplatin API Sevoflurane API Tolvaptan API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 10 2
ARCSA (EC) 8 None
MINSA (CR) 6 None
INVIMA (CO) 2 None
UZPHARM (UZ) 2 None
EDA (EG) 2 None
EMA None 9
ANVISA (Brazil) None 2

Questions about Jiangsu Hengrui

Does Jiangsu Hengrui hold a US DMF or a CEP?
Jiangsu Hengrui holds 21 active US drug master files and 6 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Jiangsu Hengrui FDA-registered?
3 sites operated by Jiangsu Hengrui carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Jiangsu Hengrui's last inspection go?
The most recent inspection on record closed on 4 April 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 11 inspections are on file.
Where does Jiangsu Hengrui manufacture?
10 registered sites are on record, in United Arab Emirates and China (Lianyugang, Shanghai and Lianyungang among others). Every site is listed on this page with the register it came from.
What does Jiangsu Hengrui make?
21 molecules are on record against Jiangsu Hengrui, including Oxaliplatin, Etoposide, Sevoflurane and Dexmedetomidine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Jiangsu Hengrui's GMP?
Current GMP certificates are on record from EMA, US FDA and ANVISA (Brazil). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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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.

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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