Suppliers / Lunan New Time Bio-Tech

Lunan New Time Bio-Tech

China Updated 9 July 2026

Lunan New Time Bio-Tech is an API manufacturer based in China. 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

Mycophenolic Acid API Sirolimus API Tacrolimus API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

Questions about Lunan New Time Bio-Tech

Does Lunan New Time Bio-Tech hold a US DMF or a CEP?
Lunan New Time Bio-Tech holds 5 active US drug master files. 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.
What does Lunan New Time Bio-Tech make?
3 molecules are on record against Lunan New Time Bio-Tech, including Sirolimus, Mycophenolic Acid and Tacrolimus. Each links through to that molecule's full manufacturer list.
Which regulators recognise Lunan New Time Bio-Tech's GMP?
Current GMP certificates are on record from MFDS (Korea). 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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Sources on this page

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