Suppliers / CSPC Ouyi Pharmaceutical

CSPC Ouyi Pharmaceutical

China 2 duplicate records merged Updated 9 July 2026

CSPC Ouyi Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and US FDA. Its GMP standing is certified by US FDA and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 5 September 2024 as VAI.

3
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
99
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 September 2024 VAI US FDA
  • 20 October 2017 NAI US FDA
  • 2 August 2017 VAI US FDA
  • 25 September 2015 VAI US FDA
  • 18 September 2015 VAI US FDA
  • 26 May 2015 VAI US FDA
  • 3 April 2014 VAI US FDA
  • 15 November 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Shijiazhuang, United Arab Emirates Not on file
China, China 2000021110
Shijiazhuang City, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Azithromycin SFDA (Saudi Arabia), US FDA 2
Indomethacin US FDA 1
Tramadol US FDA 1

Also appears on these molecule pages

Azithromycin API Ertapenem finished dose Indomethacin API Meropenem finished dose Tramadol API

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 35 None
ARCSA (EC) 24 None
US FDA 9 1
EFDA (ET) 8 None
UZPHARM (UZ) 6 None
MINSA (CR) 4 None
NAFDAC (NG) None 1

Questions about CSPC Ouyi Pharmaceutical

Does CSPC Ouyi Pharmaceutical hold a US DMF or a CEP?
CSPC Ouyi 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 CSPC Ouyi Pharmaceutical FDA-registered?
One site operated by CSPC Ouyi 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 CSPC Ouyi Pharmaceutical's last inspection go?
The most recent inspection on record closed on 5 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does CSPC Ouyi Pharmaceutical manufacture?
3 registered sites are on record, in United Arab Emirates, China and Nigeria (Shijiazhuang, China and Shijiazhuang City). Every site is listed on this page with the register it came from.
What does CSPC Ouyi Pharmaceutical make?
3 molecules are on record against CSPC Ouyi Pharmaceutical, including Azithromycin, Indomethacin and Tramadol. Each links through to that molecule's full manufacturer list.
Which regulators recognise CSPC Ouyi Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA and NAFDAC (NG). 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.

Comparing suppliers?

Choose your molecules and target markets. CSPC Ouyi Pharmaceutical comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 3 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 5 September 2024.

Comparable suppliers

Jubilant Biosys shares 2 molecules Macleods Pharmaceuticals shares 2 molecules Apitoria Pharma shares 1 molecule Hetero shares 1 molecule Alembic Pharmaceuticals shares 1 molecule

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