Suppliers / Zenji Pharmaceuticals (Suzhou)

Zenji Pharmaceuticals (Suzhou)

China Updated 9 July 2026

Zenji Pharmaceuticals (Suzhou) is an API manufacturer based in China. It holds 9 active US drug master files and 4 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by MFDS (Korea).

9
active US DMFs
4
valid CEPs
4
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Xuguan, Suzhou, China Not on file
Xuguan, Suzhou, China Not on file
Suzhou, China Not on file
China, China 3008822863

What they file, and where

Molecule Regulators Docs
Eribulin US FDA 5
Clopidogrel EDQM 2
Lanthanum Carbonate US FDA 2
Celecoxib EDQM 1
Dapagliflozin US FDA 1
Finerenone US FDA 1
Pentoxyverine Hydrogen Citrate EDQM 1

Also appears on these molecule pages

Eribulin API Finerenone API Lanthanum Carbonate API Celecoxib API Clopidogrel API Dapagliflozin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

Questions about Zenji Pharmaceuticals (Suzhou)

Does Zenji Pharmaceuticals (Suzhou) hold a US DMF or a CEP?
Zenji Pharmaceuticals (Suzhou) holds 9 active US drug master files and 4 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 Zenji Pharmaceuticals (Suzhou) FDA-registered?
One site operated by Zenji Pharmaceuticals (Suzhou) carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Zenji Pharmaceuticals (Suzhou) manufacture?
4 registered sites are on record, in China (Xuguan, Suzhou, Suzhou and China among others). Every site is listed on this page with the register it came from.
What does Zenji Pharmaceuticals (Suzhou) make?
7 molecules are on record against Zenji Pharmaceuticals (Suzhou), including Eribulin, Clopidogrel, Lanthanum Carbonate and Celecoxib. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zenji Pharmaceuticals (Suzhou)'s GMP?
Current GMP certificates are on record from MFDS (Korea). 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