Suppliers / Lunan New Time Bio-Tech

Lunan New Time Bio-Tech

Updated 9 July 2026

Lunan New Time Bio-Tech is an API manufacturer. It holds 5 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by MFDS (Korea).

5
active US DMFs
0
valid CEPs
0
registered plants
0
filings across 0 regulators

What they file, and where

Molecule Regulators Docs
Sirolimus US FDA 3
Mycophenolic Acid US FDA 1
Tacrolimus US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

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Sources on this page

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