Is LABORATORIOS SOPHIA, S.A. DE C.V. FDA approved?

LABORATORIOS SOPHIA, S.A. DE C.V. holds 1 FDA-registered establishment in Mexico. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are LABORATORIOS SOPHIA, S.A. DE C.V.'s drugs manufactured?

The FDA register lists ZAPOPAN. Registered operations: finished drug manufacture.

What drugs does LABORATORIOS SOPHIA, S.A. DE C.V. make?

5 products are listed under LABORATORIOS SOPHIA, S.A. DE C.V. in the openFDA NDC Directory, most often as solution/ drops; emulsion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

LABORATORIOS SOPHIA, S.A. DE C.V.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 5
Live patents: 0
Countries: 1
Base: Mexico

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
LABORATORIOS SOPHIA, S.A. DE C.V.	AV. PASEO DEL NORTE No. 5255, GUADALAJARA TECHNOLOGY PARK, ZAPOPAN, JALISCO 45010, Mexico (MEX)	Finished drug manufacture	1000310459810143636

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human otc drug. By marketing category: OTC MONOGRAPH DRUG 5.

Dosage form	NDCs
solution/ drops	3
emulsion	2

Route	NDCs
ophthalmic	5

Labeller name on the listing	NDCs
laboratorios sophia, s.a. de c.v.	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
OneDrop	Propylene Glycol	emulsion, ophthalmic	57619-306OTC MONOGRAPH DRUG
Splash Pure PF	propylene glycol	emulsion, ophthalmic	57619-307OTC MONOGRAPH DRUG
Splash Redness Reliever	Hypromellose, Naphazoline hydrochloride	solution/ drops, ophthalmic	57619-304OTC MONOGRAPH DRUG
Splash Refresh	Hypromellose	solution/ drops, ophthalmic	57619-305OTC MONOGRAPH DRUG
Splash Tears	Hypromellose	solution/ drops, ophthalmic	57619-303OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Fresenius Medical Care Renal Therapies Group, LLCZapopan, MEX
Alcoholera de Zapopan SA de CVZapopan, MEX
Laboratorios Zeyco SA de CVZapopan, MEX
Tecnoglobal, PH7 S.A. DE C.V.Zapopan, MEX

Compare

Comparable companies in Mexico

Schwabe Mexico, S.A. de C.V.1 site · 28 NDC
Avon Cosmetics Manufacturing, S. de R.L. de C.V.1 site · 16 NDC
Nartex Laboratorios Homeopaticos, S.A. de C.V.1 site · 14 NDC
Degasa, S.A. de C.V.1 site · 11 NDC
Aqua Medica, S.A. de C.V.1 site · 10 NDC
Selder, S.A. de C.V.1 site · 8 NDC
Iron Lab SA de CV1 site · 6 NDC
Laboratorios Zeyco SA de CV1 site · 5 NDC
Boehringer Ingelheim Promeco S.A. de C.V.1 site · 3 NDC
Grimann SA de CV1 site · 2 NDC

Enquiry

Common questions

Is LABORATORIOS SOPHIA, S.A. DE C.V. FDA approved?: LABORATORIOS SOPHIA, S.A. DE C.V. holds 1 FDA-registered establishment in Mexico. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are LABORATORIOS SOPHIA, S.A. DE C.V.'s drugs manufactured?: The FDA register lists ZAPOPAN. Registered operations: finished drug manufacture.
What drugs does LABORATORIOS SOPHIA, S.A. DE C.V. make?: 5 products are listed under LABORATORIOS SOPHIA, S.A. DE C.V. in the openFDA NDC Directory, most often as solution/ drops; emulsion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.