Suppliers / Luye Pharma

Luye Pharma

Germany 72 employees Updated 9 July 2026

Luye Pharma is a finished-dose manufacturer based in Germany. It appears in 104 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), EMA and HSA (SG). Its GMP standing is certified by ZLG (DE), HSA (SG) and MHRA (UK), among 5 authorities.

0
active US DMFs
0
valid CEPs
4
registered plants
104
filings across 12 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Miesbach, United Arab Emirates Not on file
MIESBACH, Germany Not on file
Miesbach, Germany Not on file
GUILDFORD, United Kingdom Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 33 2
EMA 13 1
HSA (SG) 12 2
SFDA (Saudi Arabia) 10 None
DH (HK) 10 None
NPRA (MY) 7 None
ZLG (DE) None 6
EAEU_EEC None 1

Questions about Luye Pharma

Does Luye Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Luye Pharma. It does have 104 filings with 12 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Luye Pharma manufacture?
4 registered sites are on record, in United Arab Emirates, Germany and United Kingdom (Miesbach, Miesbach and Guildford among others). Every site is listed on this page with the register it came from.
Which regulators recognise Luye Pharma's GMP?
Current GMP certificates are on record from ZLG (DE), HSA (SG), MHRA (UK), EEC (Eurasian Economic Union) and EMA. 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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Comparable suppliers

AESICA Pharmaceuticals also in Germany Alfred E. Tiefenbacher (GmbH also in Germany Almirall Hermal also in Germany Aqvida also in Germany Aristo Pharma also in Germany

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