Suppliers / Shandong Luye Pharmaceutical

Shandong Luye Pharmaceutical

China Updated 9 July 2026

Shandong Luye Pharmaceutical is a finished-dose manufacturer based in China. It appears in 11 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and UZPHARM (UZ). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 May 2024 as NAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
11
filings across 2 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

  • 14 May 2024 NAI 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 3004330858

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 10 1
UZPHARM (UZ) 1 None

Comparing suppliers?

Choose your molecules and target markets. Shandong Luye 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 May 2024.

Sources on this page

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