Suppliers / Shandong Lukang Pharmaceutical

Shandong Lukang Pharmaceutical

China 147 employees Updated 9 July 2026

Shandong Lukang Pharmaceutical is a finished-dose manufacturer based in China. It holds one active US drug master file and 3 valid CEPs across a filed portfolio of 4 molecules. Its filings concentrate with ARCSA (EC), NAFDAC (NG) and DAV (Vietnam). Its GMP standing is certified by NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 15 January 2016 as VAI.

1
active US DMFs
3
valid CEPs
4
registered plants 1 with an FDA FEI number
15
filings across 4 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

  • 15 January 2016 VAI US FDA
  • 16 January 2015 VAI US FDA
  • 6 April 2012 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Jining, China Not on file
Jining City, China Not on file
China, China 3002664271
P.R. China, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Levodopa EDQM 1
Spectinomycin US FDA 1
Spectinomycin Dihydrochloride Pentahydrate EDQM 1
Spectinomycin Sulfate Tetrahydrate For Veterinary Use EDQM 1

Also appears on these molecule pages

Amlodipine contract manufacturing Ampicillin contract manufacturing Benzylpenicillin finished dose Cefazolin contract manufacturing Ceftriaxone contract manufacturing Entecavir contract manufacturing Levodopa contract manufacturing Spiramycin contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 8 None
NAFDAC (NG) 3 1
DAV (Vietnam) 2 None
MINSA (CR) 2 None

Questions about Shandong Lukang Pharmaceutical

Does Shandong Lukang Pharmaceutical hold a US DMF or a CEP?
Shandong Lukang Pharmaceutical holds 1 active US drug master file and 3 valid CEPs. 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 Lukang Pharmaceutical FDA-registered?
One site operated by Shandong Lukang 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 Lukang Pharmaceutical's last inspection go?
The most recent inspection on record closed on 15 January 2016 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Shandong Lukang Pharmaceutical manufacture?
4 registered sites are on record, in China and Nigeria (Jining, Jining City and China among others). Every site is listed on this page with the register it came from.
What does Shandong Lukang Pharmaceutical make?
4 molecules are on record against Shandong Lukang Pharmaceutical, including Levodopa, Spectinomycin, Spectinomycin Dihydrochloride Pentahydrate and Spectinomycin Sulfate Tetrahydrate For Veterinary Use. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Lukang Pharmaceutical's GMP?
Current GMP certificates are on record from NAFDAC (NG). 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 15 January 2016.

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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