Suppliers / Fujian South Pharmaceutical

Fujian South Pharmaceutical

China Updated 9 July 2026

Fujian South Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 October 2024 as NAI.

5
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 October 2024 NAI US FDA
  • 25 September 2015 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 3008467694

What they file, and where

Molecule Regulators Docs
Paclitaxel SFDA (Saudi Arabia), US FDA 3
Acetylcysteine US FDA 1
Bendamustine SFDA (Saudi Arabia) 1
Cytarabine US FDA 1
Docetaxel US FDA 1
Fluorouracil US FDA 1
Pemetrexed Disodium Hemipentahydrate SFDA (Saudi Arabia) 1
Sodium Thiosulfate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acetylcysteine API Bendamustine API Cytarabine API Docetaxel API Fluorouracil API Paclitaxel API Pemetrexed finished dose Pemetrexed Disodium Hemipentahydrate API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
US FDA None 1

Questions about Fujian South Pharmaceutical

Does Fujian South Pharmaceutical hold a US DMF or a CEP?
Fujian South 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 South Pharmaceutical FDA-registered?
One site operated by Fujian South 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 South Pharmaceutical's last inspection go?
The most recent inspection on record closed on 11 October 2024 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Fujian South 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 Fujian South Pharmaceutical make?
8 molecules are on record against Fujian South Pharmaceutical, including Paclitaxel, Acetylcysteine, Bendamustine and Cytarabine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fujian South 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 11 October 2024.

Comparable suppliers

MSN Laboratories shares 3 molecules Hetero shares 3 molecules Dr Reddy's Laboratories shares 2 molecules Shilpa Pharma Lifesciences shares 2 molecules ScinoPharm Taiwan shares 2 molecules

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