Suppliers / zhejiang jiuzhou pharmaceutical

zhejiang jiuzhou pharmaceutical

China 603456.SS Updated 9 July 2026

zhejiang jiuzhou pharmaceutical is an API manufacturer based in China. It holds 8 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 23 August 2024 as NAI.

8
active US DMFs
0
valid CEPs
1
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
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 23 August 2024 NAI US FDA
  • 13 September 2018 VAI US FDA
  • 23 January 2016 VAI US FDA
  • 24 October 2013 OAI US FDA
  • 21 April 2011 VAI 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 3003744377

What they file, and where

Molecule Regulators Docs
Imatinib SFDA (Saudi Arabia), US FDA 2
Sulfadimethoxine US FDA 2
Acyclovir US FDA 1
Gefitinib US FDA 1
Gliclazide SFDA (Saudi Arabia) 1
Imatinib Mesilate SFDA (Saudi Arabia) 1
Oxcarbazepine US FDA 1
Sildenafil US FDA 1
Sitagliptin US FDA 1
Sulfasalazine SFDA (Saudi Arabia) 1
Show all 11 molecules on file
Tenofovir Disoproxil SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Abacavir contract manufacturing Acyclovir API Axitinib contract manufacturing Bezafibrate contract manufacturing Carbamazepine contract manufacturing Dexketoprofen contract manufacturing Dimethyl contract manufacturing Duloxetine contract manufacturing Erlotinib contract manufacturing Gefitinib contract manufacturing Gliclazide contract manufacturing Imatinib contract manufacturing
Show 9 more molecule pages
Imatinib Mesilate API Ketoprofen contract manufacturing Meropenem contract manufacturing Oxcarbazepine contract manufacturing Paroxetine contract manufacturing Sildenafil API Sitagliptin contract manufacturing Venlafaxine contract manufacturing Tenofovir Disoproxil API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about zhejiang jiuzhou pharmaceutical

Does zhejiang jiuzhou pharmaceutical hold a US DMF or a CEP?
zhejiang jiuzhou pharmaceutical holds 8 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 zhejiang jiuzhou pharmaceutical FDA-registered?
One site operated by zhejiang jiuzhou 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 zhejiang jiuzhou pharmaceutical's last inspection go?
The most recent inspection on record closed on 23 August 2024 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file, of which 1 closed as OAI.
Where does zhejiang jiuzhou pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does zhejiang jiuzhou pharmaceutical make?
11 molecules are on record against zhejiang jiuzhou pharmaceutical, including Imatinib, Sulfadimethoxine, Acyclovir and Gefitinib. Each links through to that molecule's full manufacturer list.
Which regulators recognise zhejiang jiuzhou pharmaceutical's GMP?
Current GMP certificates are on record from US FDA. 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 23 August 2024.

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