Suppliers / Changzhou Syntheall Pharmaceutical

Changzhou Syntheall Pharmaceutical

China Updated 9 July 2026

Changzhou Syntheall Pharmaceutical is a finished-dose manufacturer based in China. It appears in 5 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR) and ARCSA (EC). Its GMP standing is certified by MFDS (Korea), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as NAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
5
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 7 March 2025 NAI US FDA
  • 19 July 2019 NAI US FDA

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

Registered plants

Site FDA FEI
China, China 3012897823
Changzhou, China Not on file

What they file, and where

Molecule Regulators Docs
Fedratinib SFDA (Saudi Arabia) 1
Ibrutinib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Ibrutinib finished dose Ritonavir finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None
ARCSA (EC) 1 None
MFDS (Korea) None 2
US FDA None 1
EMA None 1

Questions about Changzhou Syntheall Pharmaceutical

Does Changzhou Syntheall Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Changzhou Syntheall Pharmaceutical. It does have 5 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Changzhou Syntheall Pharmaceutical FDA-registered?
One site operated by Changzhou Syntheall Pharmaceutical 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.
How did Changzhou Syntheall Pharmaceutical's last inspection go?
The most recent inspection on record closed on 7 March 2025 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Changzhou Syntheall Pharmaceutical manufacture?
2 registered sites are on record, in China (China and Changzhou). Every site is listed on this page with the register it came from.
What does Changzhou Syntheall Pharmaceutical make?
2 molecules are on record against Changzhou Syntheall Pharmaceutical, including Fedratinib and Ibrutinib. Each links through to that molecule's full manufacturer list.
Which regulators recognise Changzhou Syntheall Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea), US FDA and 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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Open risk flags

  • The most recent inspection outcome was NAI, on 7 March 2025.

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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