Suppliers / Ningxia Qiyuan Pharmaceutical

Ningxia Qiyuan Pharmaceutical

China Updated 9 July 2026

Ningxia Qiyuan Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 5 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 28 June 2019 as VAI.

3
active US DMFs
5
valid CEPs
4
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
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

  • 28 June 2019 VAI US FDA
  • 28 April 2016 VAI US FDA
  • 12 September 2014 VAI US FDA
  • 28 September 2012 VAI US FDA
  • 6 May 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Yingchuan, China Not on file
China, China 3004341367
Yinchuan, China Not on file
Yinchuan City, China Not on file

What they file, and where

Molecule Regulators Docs
Erythromycin EDQM, US FDA 4
Tetracycline EDQM, US FDA 2
Ascorbic Acid EDQM 1
Azithromycin EDQM 1

Also appears on these molecule pages

Azithromycin API Erythromycin API Tetracycline API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Ningxia Qiyuan Pharmaceutical

Does Ningxia Qiyuan Pharmaceutical hold a US DMF or a CEP?
Ningxia Qiyuan Pharmaceutical holds 3 active US drug master files and 5 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 Ningxia Qiyuan Pharmaceutical FDA-registered?
One site operated by Ningxia Qiyuan 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 Ningxia Qiyuan Pharmaceutical's last inspection go?
The most recent inspection on record closed on 28 June 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Ningxia Qiyuan Pharmaceutical manufacture?
4 registered sites are on record, in China (Yingchuan, China and Yinchuan among others). Every site is listed on this page with the register it came from.
What does Ningxia Qiyuan Pharmaceutical make?
4 molecules are on record against Ningxia Qiyuan Pharmaceutical, including Erythromycin, Tetracycline, Ascorbic Acid and Azithromycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ningxia Qiyuan Pharmaceutical's GMP?
Current GMP certificates are on record from EMA. 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 28 June 2019.

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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