Suppliers / Laboratórios Sophia S.A. De C.V

Laboratórios Sophia S.A. De C.V

Mexico Updated 9 July 2026

Laboratórios Sophia S.A. De C.V is a finished-dose manufacturer based in Mexico. It appears in 154 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), DIGEMAPS (DO) and INVIMA (CO). Its GMP standing is certified by COFEPRIS (MX) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 14 December 2018 as VAI. Customs aggregates show $194K of exports covering 7 molecules to 2 destinations in 2023.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
154
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 December 2018 VAI US FDA
  • 28 August 2015 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Mexico, Mexico 1000310459
ZAPOPAN, Mexico Not on file
Zapopan, Mexico Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 59 None
DIGEMAPS (DO) 40 None
INVIMA (CO) 28 None
MINSA (CR) 17 None
ANMAT (AR) 8 None
COFEPRIS (MX) 2 4
ANVISA (Brazil) None 1

Scale

Year Revenue Exports Destinations
2023 Not reported $194K 2
2022 Not reported $98K 1

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Laboratórios Sophia S.A. De C.V

Does Laboratórios Sophia 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 Laboratórios Sophia S.A. De C.V. It does have 154 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Laboratórios Sophia S.A. De C.V FDA-registered?
One site operated by Laboratórios Sophia 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.
How did Laboratórios Sophia S.A. De C.V's last inspection go?
The most recent inspection on record closed on 14 December 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Laboratórios Sophia S.A. De C.V manufacture?
3 registered sites are on record, in Mexico (Mexico, Zapopan and Zapopan). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratórios Sophia 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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Open risk flags

  • The most recent inspection outcome was VAI, on 14 December 2018.

Comparable suppliers

Abbott Laboratories De México, S. A. De C. V also in Mexico Armstrong Laboratorios De México, S.A. De C.V also in Mexico Bayer De Mexico, S.A. De C.V also in Mexico Fermic, s.a. de c.v also in Mexico Grimann, S.A. de C.V also in Mexico

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
Customs aggregates
Export values, molecule and destination counts