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 City, China Not on file
Shouguang, 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

Clozapine contract manufacturing Esomeprazole API Itraconazole contract manufacturing Lansoprazole contract manufacturing Metformin contract manufacturing Nifedipine API Omeprazole contract manufacturing Pantoprazole contract manufacturing Phloroglucinol contract manufacturing Rabeprazole API 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

Questions about Shouguang Fukang Pharmaceutical

Does Shouguang Fukang Pharmaceutical hold a US DMF or a CEP?
Shouguang Fukang Pharmaceutical holds 11 active US drug master files and 18 valid CEPs. 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 Shouguang Fukang Pharmaceutical FDA-registered?
One site operated by Shouguang 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 Shouguang Fukang Pharmaceutical's last inspection go?
The most recent inspection on record closed on 21 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Shouguang Fukang Pharmaceutical manufacture?
3 registered sites are on record, in China (Shouguang City, Shouguang and China). Every site is listed on this page with the register it came from.
What does Shouguang Fukang Pharmaceutical make?
12 molecules are on record against Shouguang Fukang Pharmaceutical, including Omeprazole, Esomeprazole, Clozapine and Lansoprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shouguang Fukang Pharmaceutical's GMP?
Current GMP certificates are on record from EMA and 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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  • The most recent inspection outcome was VAI, on 21 February 2025.

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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