Suppliers / Laboratorios Poen S.A.U

Laboratorios Poen S.A.U

Argentina Updated 9 July 2026

Laboratorios Poen S.A.U is a finished-dose manufacturer based in Argentina. It appears in 165 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and ANMAT (AR). Its GMP standing is certified by INVIMA (CO).

0
active US DMFs
0
valid CEPs
2
registered plants
165
filings across 5 regulators

Registered plants

Site FDA FEI
BUENOS AIRES, Argentina Not on file
Ciudad Autonaoma De Buenos Aires, Colombia Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 53 None
ARCSA (EC) 43 None
ANMAT (AR) 37 None
MINSA (CR) 21 None
INVIMA (CO) 11 1

Questions about Laboratorios Poen S.A.U

Does Laboratorios Poen S.A.U hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorios Poen S.A.U. It does have 165 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Laboratorios Poen S.A.U manufacture?
2 registered sites are on record, in Argentina and Colombia (Buenos Aires and Ciudad Autonaoma De Buenos Aires). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorios Poen S.A.U'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