Suppliers / Fujian Fukang Pharmaceutical

Fujian Fukang Pharmaceutical

China Updated 9 July 2026

Fujian Fukang Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 12 April 2024 as NAI.

5
active US DMFs
0
valid CEPs
2
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
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

  • 12 April 2024 NAI US FDA
  • 26 July 2018 VAI US FDA
  • 28 March 2014 VAI US FDA
  • 23 September 2011 NAI US FDA
  • 19 February 2009 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 3004752070
Fuzhou, China Not on file

What they file, and where

Molecule Regulators Docs
Gentamicin SFDA (Saudi Arabia), US FDA 2
Oseltamivir US FDA 2
Chlortetracycline US FDA 1
Tetracycline US FDA 1

Also appears on these molecule pages

Gentamicin API Oseltamivir API Tetracycline API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Questions about Fujian Fukang Pharmaceutical

Does Fujian Fukang Pharmaceutical hold a US DMF or a CEP?
Fujian Fukang Pharmaceutical holds 5 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 Fujian Fukang Pharmaceutical FDA-registered?
One site operated by Fujian Fukang 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 Fujian Fukang Pharmaceutical's last inspection go?
The most recent inspection on record closed on 12 April 2024 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Fujian Fukang Pharmaceutical manufacture?
2 registered sites are on record, in China (China and Fuzhou). Every site is listed on this page with the register it came from.
What does Fujian Fukang Pharmaceutical make?
4 molecules are on record against Fujian Fukang Pharmaceutical, including Gentamicin, Oseltamivir, Chlortetracycline and Tetracycline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fujian Fukang Pharmaceutical's GMP?
Current GMP certificates are on record from 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.

Comparing suppliers?

Choose your molecules and target markets. Fujian Fukang Pharmaceutical comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 12 April 2024.

Comparable suppliers

Hetero shares 1 molecule Cipla shares 1 molecule Matrix Pharmacorp shares 1 molecule Zydus Lifesciences shares 1 molecule Macleods Pharmaceuticals shares 1 molecule

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