Suppliers / Laboratorios Silanes, S.A. De C.V

Laboratorios Silanes, S.A. De C.V

Mexico Updated 9 July 2026

Laboratorios Silanes, S.A. De C.V is a finished-dose manufacturer based in Mexico. It appears in 59 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by COFEPRIS (MX) and ANVISA (Brazil).

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
59
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
TOLUCA, Mexico Not on file
Toluca, Mexico Not on file
Miguel Hidalgo, Mexico Not on file
Benito Juárez, Mexico Not on file
Mexico, Mexico 3006664611

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 30 None
MINSA (CR) 12 None
INVIMA (CO) 10 None
ARCSA (EC) 4 None
AEMPS (ES) 2 None
COFEPRIS (MX) 1 4
ANVISA (Brazil) None 1

Questions about Laboratorios Silanes, S.A. De C.V

Does Laboratorios Silanes, S.A. De C.V hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorios Silanes, S.A. De C.V. It does have 59 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Laboratorios Silanes, S.A. De C.V FDA-registered?
One site operated by Laboratorios Silanes, S.A. De C.V 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 Laboratorios Silanes, S.A. De C.V manufacture?
5 registered sites are on record, in Mexico (Toluca, Toluca and Miguel Hidalgo among others). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorios Silanes, S.A. De C.V's GMP?
Current GMP certificates are on record from COFEPRIS (MX) and ANVISA (Brazil). 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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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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