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

Questions about Shandong Luye Pharmaceutical

Does Shandong Luye Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Shandong Luye Pharmaceutical. It does have 11 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Shandong Luye Pharmaceutical FDA-registered?
One site operated by Shandong Luye 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 Luye Pharmaceutical's last inspection go?
The most recent inspection on record closed on 14 May 2024 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Shandong Luye Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
Which regulators recognise Shandong Luye 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.

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Open risk flags

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

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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