Suppliers / Laboratorios Andrómaco

Laboratorios Andrómaco

Chile 2 duplicate records merged Updated 9 July 2026

Laboratorios Andrómaco is a finished-dose manufacturer based in Chile. It appears in 496 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with ISP (CL), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil) and ISP (CL).

0
active US DMFs
0
valid CEPs
1
registered plants
496
filings across 7 regulators

Registered plants

Site FDA FEI
SANTIAGO, Chile Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ISP (CL) 245 1
ARCSA (EC) 91 None
MINSA (CR) 82 None
ANMAT (AR) 36 None
INHRR (VE) 22 None
INFARMED (PT) 16 None
ANVISA (Brazil) None 1

Questions about Laboratorios Andrómaco

Does Laboratorios Andrómaco hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorios Andrómaco. It does have 496 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Laboratorios Andrómaco manufacture?
1 registered site is on record, in Chile (Santiago). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorios Andrómaco's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and ISP (CL). 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