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

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Open risk flags

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

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates