Suppliers / Jiangsu Alpha Pharmaceutical

Jiangsu Alpha Pharmaceutical

China Updated 9 July 2026

Jiangsu Alpha Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 25 January 2019 as VAI.

3
active US DMFs
0
valid CEPs
1
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
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 25 January 2019 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 3011765771

What they file, and where

Molecule Regulators Docs
Atorvastatin US FDA 1
Dabigatran US FDA 1
Rosuvastatin US FDA 1

Also appears on these molecule pages

Dabigatran API Atorvastatin API Rosuvastatin API

Questions about Jiangsu Alpha Pharmaceutical

Does Jiangsu Alpha Pharmaceutical hold a US DMF or a CEP?
Jiangsu Alpha Pharmaceutical holds 3 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 Jiangsu Alpha Pharmaceutical FDA-registered?
One site operated by Jiangsu Alpha 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 Jiangsu Alpha Pharmaceutical's last inspection go?
The most recent inspection on record closed on 25 January 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Jiangsu Alpha 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 Jiangsu Alpha Pharmaceutical make?
3 molecules are on record against Jiangsu Alpha Pharmaceutical, including Atorvastatin, Dabigatran and Rosuvastatin. Each links through to that molecule's full manufacturer list.

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 25 January 2019.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability