Suppliers / Kronos Laboratorios

Kronos Laboratorios

Ecuador Updated 9 July 2026

Kronos Laboratorios is a finished-dose manufacturer based in Ecuador. It appears in 256 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ARCSA (EC).

0
active US DMFs
0
valid CEPs
0
registered plants
256
filings across 1 regulators

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 256 2

Limited public record

Beyond the filing counts above, the public registers hold no plant, inspection or portfolio detail for this company as at 9 July 2026. We report that as a gap rather than inferring an answer.

Questions about Kronos Laboratorios

Does Kronos Laboratorios hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Kronos Laboratorios. It does have 256 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Which regulators recognise Kronos Laboratorios's GMP?
Current GMP certificates are on record from ARCSA (EC). 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.

Comparing suppliers?

Choose your molecules and target markets. Kronos Laboratorios comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates