Suppliers / STADA Arzneimittel

STADA Arzneimittel

Germany Updated 9 July 2026

STADA Arzneimittel is a finished-dose manufacturer based in Germany. It appears in 2,256 regulatory filings across 16 regulators, without an active US DMF or CEP on file. Its filings concentrate with MPA (SE), EMA and INFARMED (PT). Its GMP standing is certified by ZLG (DE), EMA and EAEU_EEC, among 4 authorities.

0
active US DMFs
0
valid CEPs
4
registered plants
2,256
filings across 16 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
Bad Vilbel, United Arab Emirates Not on file
Vienna, Austria Not on file
Hassia, Germany Not on file
Bad Vilbel, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
MPA (SE) 953 None
EMA 754 2
INFARMED (PT) 139 None
URPL (PL) 125 None
FAMHP (BE) 100 None
AIFA (IT) 40 None
ZLG (DE) None 4
EAEU_EEC None 1
NCELS (KZ) None 1

Questions about STADA Arzneimittel

Does STADA Arzneimittel hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for STADA Arzneimittel. It does have 2,256 filings with 16 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does STADA Arzneimittel manufacture?
4 registered sites are on record, in United Arab Emirates, Austria and Germany (Bad Vilbel, Vienna and Hassia among others). Every site is listed on this page with the register it came from.
Which regulators recognise STADA Arzneimittel's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, EEC (Eurasian Economic Union) and NCELS (KZ). 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