Suppliers / Salutas Pharma

Salutas Pharma

Germany 223 employees 2 duplicate records merged Updated 9 July 2026

Salutas Pharma is a finished-dose manufacturer based in Germany. It appears in 64 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with UZPHARM (UZ), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EAEU_EEC, among 5 authorities.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
64
filings across 5 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
Sulzetal, United Arab Emirates Not on file
Barleben, United Arab Emirates Not on file
BARLEBEN, Germany Not on file
Suelzetal, Germany Not on file
Saxony-Anhalt, Germany Not on file
Germany, Germany 3016816013

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 24 None
ARCSA (EC) 22 None
MINSA (CR) 10 None
NAFDAC (NG) 7 1
DAV (Vietnam) 1 None
ZLG (DE) None 8
ANVISA (Brazil) None 2
EAEU_EEC None 2
EMA None 2

Questions about Salutas Pharma

Does Salutas Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Salutas Pharma. It does have 64 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Salutas Pharma FDA-registered?
One site operated by Salutas Pharma 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 Salutas Pharma manufacture?
7 registered sites are on record, in United Arab Emirates, Germany and Nigeria (Sulzetal, Barleben and Barleben among others). Every site is listed on this page with the register it came from.
Which regulators recognise Salutas Pharma's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EEC (Eurasian Economic Union), EMA and NAFDAC (NG). 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