Suppliers / Shandong Luxi Pharmaceutical

Shandong Luxi Pharmaceutical

China Updated 9 July 2026

Shandong Luxi Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 February 2025 as VAI.

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
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 February 2025 VAI US FDA
  • 24 July 2019 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 3011615110

What they file, and where

Molecule Regulators Docs
Polymyxin B US FDA 1

Also appears on these molecule pages

Polymyxin B API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Shandong Luxi Pharmaceutical

Does Shandong Luxi Pharmaceutical hold a US DMF or a CEP?
Shandong Luxi 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 Luxi Pharmaceutical FDA-registered?
One site operated by Shandong Luxi 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 Luxi Pharmaceutical's last inspection go?
The most recent inspection on record closed on 28 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Shandong Luxi 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 Luxi Pharmaceutical make?
1 molecule is on record against Shandong Luxi Pharmaceutical, including Polymyxin B. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Luxi 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 VAI, on 28 February 2025.

Comparable suppliers

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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