Suppliers / Jiangxi Fushine Pharmaceutical

Jiangxi Fushine Pharmaceutical

China Updated 9 July 2026

Jiangxi Fushine Pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 August 2025 as VAI.

2
active US DMFs
1
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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 August 2025 VAI US FDA
  • 18 January 2019 NAI US FDA
  • 4 July 2014 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Jingdezhen City, China Not on file
China, China 3008177143

What they file, and where

Molecule Regulators Docs
Piperacillin EDQM, US FDA 2
Sulbactam US FDA 1

Also appears on these molecule pages

Piperacillin API Sulbactam API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Jiangxi Fushine Pharmaceutical

Does Jiangxi Fushine Pharmaceutical hold a US DMF or a CEP?
Jiangxi Fushine Pharmaceutical holds 2 active US drug master files and 1 valid CEP. 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 Jiangxi Fushine Pharmaceutical FDA-registered?
One site operated by Jiangxi Fushine 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 Jiangxi Fushine Pharmaceutical's last inspection go?
The most recent inspection on record closed on 14 August 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Jiangxi Fushine Pharmaceutical manufacture?
2 registered sites are on record, in China (Jingdezhen City and China). Every site is listed on this page with the register it came from.
What does Jiangxi Fushine Pharmaceutical make?
2 molecules are on record against Jiangxi Fushine Pharmaceutical, including Piperacillin and Sulbactam. Each links through to that molecule's full manufacturer list.
Which regulators recognise Jiangxi Fushine 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 VAI, on 14 August 2025.

Comparable suppliers

Apitoria Pharma shares 2 molecules Acs Dobfar shares 2 molecules Shandong Anxin Pharmaceutical shares 2 molecules Inner Mongolia Changsheng Pharmaceutical shares 2 molecules Istituto Biochimico Italiano Giovanni Lorenzini 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