Suppliers / hameln pharma

hameln pharma

Germany 74 employees Updated 9 July 2026

hameln pharma is a finished-dose manufacturer based in Germany. It appears in 502 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, MHRA (UK) and AIFA (IT). Its GMP standing is certified by ZLG (DE) and EMA.

0
active US DMFs
0
valid CEPs
4
registered plants
502
filings across 14 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
Niedersachsen, Germany Not on file
Lower Saxony, Germany Not on file
Hameln, Germany Not on file
Hameln, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 164 3
MHRA (UK) 116 None
AIFA (IT) 77 None
MPA (SE) 35 None
DKMA (DK) 31 None
INFARMED (PT) 21 None
ZLG (DE) None 18

Questions about hameln pharma

Does hameln pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for hameln pharma. It does have 502 filings with 14 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does hameln pharma manufacture?
4 registered sites are on record, in Germany (Niedersachsen, Lower Saxony and Hameln among others). Every site is listed on this page with the register it came from.
Which regulators recognise hameln pharma's GMP?
Current GMP certificates are on record from ZLG (DE) 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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Sources on this page

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