Suppliers / Yangtze River Pharmaceutical Group Jiangsu Haici Biological

Yangtze River Pharmaceutical Group Jiangsu Haici Biological

China 934 employees Updated 9 July 2026

Yangtze River Pharmaceutical Group Jiangsu Haici Biological Pharmaceutical is an API manufacturer based in China. It holds 25 active US drug master files across a filed portfolio of 25 molecules. Its filings concentrate with NPRA (MY), AEMPS (ES) and MINSA (CR). Its GMP standing is certified by EMA.

25
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
16
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Taizhou, China Not on file
China, China 3009173840
China, China 3030810525

What they file, and where

Molecule Regulators Docs
Afatinib US FDA 1
Aripiprazole US FDA 1
Dexmedetomidine US FDA 1
Dexrazoxane US FDA 1
Diquafosol US FDA 1
Doxofylline US FDA 1
Edaravone US FDA 1
Empagliflozin US FDA 1
Esomeprazole US FDA 1
Gemcitabine US FDA 1
Show all 25 molecules on file
Glimepiride US FDA 1
Lenalidomide US FDA 1
Lenvatinib US FDA 1
Levosimendan US FDA 1
Linagliptin US FDA 1
Milrinone US FDA 1
Parecoxib US FDA 1
Pramipexole US FDA 1
Propofol US FDA 1
Regorafenib US FDA 1
Sitafloxacin US FDA 1
Sugammadex US FDA 1
Tamoxifen US FDA 1
Tedizolid US FDA 1
Tofacitinib US FDA 1

Also appears on these molecule pages

Show 8 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 10 None
AEMPS (ES) 3 None
MINSA (CR) 2 None
ARCSA (EC) 1 None
EMA None 1

Questions about Yangtze River Pharmaceutical Group Jiangsu Haici Biological

Does Yangtze River Pharmaceutical Group Jiangsu Haici Biological hold a US DMF or a CEP?
Yangtze River Pharmaceutical Group Jiangsu Haici Biological holds 25 active US drug master files. 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 Yangtze River Pharmaceutical Group Jiangsu Haici Biological FDA-registered?
2 sites operated by Yangtze River Pharmaceutical Group Jiangsu Haici Biological 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.
Where does Yangtze River Pharmaceutical Group Jiangsu Haici Biological manufacture?
3 registered sites are on record, in China (Taizhou and China among others). Every site is listed on this page with the register it came from.
What does Yangtze River Pharmaceutical Group Jiangsu Haici Biological make?
25 molecules are on record against Yangtze River Pharmaceutical Group Jiangsu Haici Biological, including Afatinib, Aripiprazole, Dexmedetomidine and Dexrazoxane. Each links through to that molecule's full manufacturer list.
Which regulators recognise Yangtze River Pharmaceutical Group Jiangsu Haici Biological's GMP?
Current GMP certificates are on record from EMA. 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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Sources on this page

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