Suppliers / Klocke Pharma-Service

Klocke Pharma-Service

Germany Updated 9 July 2026

Klocke Pharma-Service is a finished-dose manufacturer based in Germany. It appears in 18 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), DIGEMAPS (DO) and MINSA (CR). Its GMP standing is certified by ZLG (DE), EMA and EAEU_EEC, among 4 authorities.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
18
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Appenweier, United Arab Emirates Not on file
BADEN-WÜRTTEMBERG, Germany Not on file
Baden-Wuerttemberg, Germany Not on file
Willstaett, Germany Not on file
Germany, Germany 3005547652
Appenweier, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 4 None
DIGEMAPS (DO) 4 None
MINSA (CR) 4 None
NPRA (MY) 3 None
INVIMA (CO) 1 None
EDE (AE) 1 None
ZLG (DE) None 10
EMA None 1
EAEU_EEC None 1
ANVISA (Brazil) None 1

Questions about Klocke Pharma-Service

Does Klocke Pharma-Service hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Klocke Pharma-Service. It does have 18 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Klocke Pharma-Service FDA-registered?
One site operated by Klocke Pharma-Service carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Klocke Pharma-Service manufacture?
6 registered sites are on record, in United Arab Emirates and Germany (Appenweier, Baden-württemberg and Baden-wuerttemberg among others). Every site is listed on this page with the register it came from.
Which regulators recognise Klocke Pharma-Service's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, EEC (Eurasian Economic Union) and ANVISA (Brazil). 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