Suppliers / Laboratorios Clausen

Laboratorios Clausen

Uruguay Updated 9 July 2026

Laboratorios Clausen is a finished-dose manufacturer based in Uruguay. It appears in 34 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), MINSA (CR) and ARCSA (EC). Its GMP standing is certified by INVIMA (CO).

0
active US DMFs
0
valid CEPs
2
registered plants
34
filings across 3 regulators

Registered plants

Site FDA FEI
Montevideo, Colombia Not on file
MONTEVIDEO, Uruguay Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 27 None
MINSA (CR) 5 None
ARCSA (EC) 2 None
INVIMA (CO) None 1

Questions about Laboratorios Clausen

Does Laboratorios Clausen hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorios Clausen. It does have 34 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Laboratorios Clausen manufacture?
2 registered sites are on record, in Colombia and Uruguay (Montevideo and Montevideo). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorios Clausen's GMP?
Current GMP certificates are on record from INVIMA (CO). 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