Shandong Lukang Pharmaceutical is a contract 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.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Jining City, China | Not on file |
| Jining, China | Not on file |
| China, China | 3002664271 |
| P.R. China, Nigeria | Not on file |
| 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
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 8 | None |
| NAFDAC (NG) | 3 | 1 |
| DAV (Vietnam) | 2 | None |
| MINSA (CR) | 2 | None |
Choose your molecules and target markets. Shandong Lukang Pharmaceutical comes back tiered against every other supplier able to file there.
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