Suppliers / Shouguang Fukang Pharmaceutical

Shouguang Fukang Pharmaceutical

China Updated 9 July 2026

Shouguang Fukang Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files and 18 valid CEPs across a filed portfolio of 12 molecules. Its filings concentrate with EFDA (ET) and MINSA (CR). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 21 February 2025 as VAI.

11
active US DMFs
18
valid CEPs
3
registered plants 1 with an FDA FEI number
3
filings across 2 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

  • 21 February 2025 VAI US FDA
  • 25 May 2018 VAI US FDA
  • 16 September 2016 NAI US FDA
  • 6 June 2014 VAI US FDA
  • 31 March 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
Shouguang, China Not on file
Shouguang City, China Not on file
China, China 3003941038

What they file, and where

Molecule Regulators Docs
Omeprazole EDQM, US FDA 7
Esomeprazole EDQM, US FDA 6
Clozapine EDQM, US FDA 2
Lansoprazole EDQM, US FDA 2
Metformin SFDA (Saudi Arabia), US FDA 2
Pantoprazole EDQM, US FDA 2
Phloroglucinol EDQM 2
Sulfamethoxazole EDQM, US FDA 2
Trimethoprim EDQM, US FDA 2
Metformin Hydrochloride EDQM 1
Show all 12 molecules on file
Nifedipine EDQM 1
Rabeprazole EDQM 1

Also appears on these molecule pages

Esomeprazole API Itraconazole contract manufacturing Lansoprazole contract manufacturing Metformin contract manufacturing Nifedipine API Omeprazole contract manufacturing Pantoprazole contract manufacturing Sulfamethoxazole contract manufacturing Trimethoprim contract manufacturing

Filings and GMP by regulator

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

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Open risk flags

  • The most recent inspection outcome was VAI, on 21 February 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates