Suppliers / Shandong Keyuan Pharmaceutical

Shandong Keyuan Pharmaceutical

China Updated 9 July 2026

Shandong Keyuan Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file 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 June 2024 as NAI.

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

Inspection history

  • 14 June 2024 NAI US FDA
  • 2 August 2018 NAI US FDA
  • 10 April 2015 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 3007607025

What they file, and where

Molecule Regulators Docs
Gliclazide SFDA (Saudi Arabia) 1
Metformin US FDA 1

Also appears on these molecule pages

Gliclazide API Metformin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Shandong Keyuan Pharmaceutical

Does Shandong Keyuan Pharmaceutical hold a US DMF or a CEP?
Shandong Keyuan Pharmaceutical holds 1 active US drug master file. 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 Shandong Keyuan Pharmaceutical FDA-registered?
One site operated by Shandong Keyuan 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 Shandong Keyuan Pharmaceutical's last inspection go?
The most recent inspection on record closed on 14 June 2024 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Shandong Keyuan 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 Shandong Keyuan Pharmaceutical make?
2 molecules are on record against Shandong Keyuan Pharmaceutical, including Gliclazide and Metformin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Keyuan 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.

Comparing suppliers?

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

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 14 June 2024.

Comparable suppliers

Granules India shares 2 molecules Sohan Healthcare shares 2 molecules Apitoria Pharma shares 1 molecule Olon shares 1 molecule Ipca Laboratories 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