Is Aqua Medica, S.A. de C.V. FDA approved?

Aqua Medica, 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 Aqua Medica, S.A. de C.V.'s drugs manufactured?

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

What drugs does Aqua Medica, S.A. de C.V. make?

10 products are listed under Aqua Medica, S.A. de C.V. in the openFDA NDC Directory, most often as solution, concentrate; gel; powder, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aqua Medica, 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: 10
Live patents: 0
Countries: 1
Base: Mexico

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aqua Medica, S.A. de C.V.	Carr. Federal Mexico Cuautla Km 65.8 No.8 Tetelcingo, Cuautla, Morelos 62757, Mexico (MEX)	Finished drug manufacture	3019430653589696442

Catalogue

Drug listings by form and route

10 active NDC listings: 10 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 10.

Dosage form	NDCs
solution, concentrate	8
gel	1
powder, for solution	1

Route	NDCs
hemodialysis	9
topical	1

Labeller name on the listing	NDCs
aqua medica, s.a. de c.v.	10

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AQUACETIC-30	Cleaning Solution for Hemodialysis Machines	solution, concentrate, hemodialysis	81943-801UNAPPROVED DRUG OTHER
AQUACID-100	Acid Concentrate for Hemodialysis	solution, concentrate, hemodialysis	81943-605UNAPPROVED DRUG OTHER
AQUACID-120	Acid Concentrate for Hemodialysis	solution, concentrate, hemodialysis	81943-604UNAPPROVED DRUG OTHER
AQUACID-200	Acid Concentrate for Hemodialysis	solution, concentrate, hemodialysis	81943-603UNAPPROVED DRUG OTHER
AQUACID-220	Acid Concentrate for Hemodialysis	solution, concentrate, hemodialysis	81943-602UNAPPROVED DRUG OTHER
CITRACID-50	Desinfectant Solution for Hemodialysis Machine	solution, concentrate, hemodialysis	81943-701UNAPPROVED DRUG OTHER
DRY-CID	Dry Concentrate for Hemodialysis	powder, for solution, hemodialysis	81943-601UNAPPROVED DRUG OTHER
QUABIC-100	Hemodialysis Grade Sodium Bicarbonate Solution	solution, concentrate, hemodialysis	81943-503UNAPPROVED DRUG OTHER
QUABIC-300	Hemodialysis Grade Sodium Bicarbonate Solution	solution, concentrate, hemodialysis	81943-502UNAPPROVED DRUG OTHER
X-TERIL	ALCOHOL	gel, topical	81943-203UNAPPROVED DRUG OTHER

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LABORATORIOS SOPHIA, S.A. DE C.V.1 site · 5 NDC
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Boehringer Ingelheim Promeco S.A. de C.V.1 site · 3 NDC
Grimann SA de CV1 site · 2 NDC

Enquiry

Common questions

Is Aqua Medica, S.A. de C.V. FDA approved?: Aqua Medica, 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 Aqua Medica, S.A. de C.V.'s drugs manufactured?: The FDA register lists Cuautla. Registered operations: finished drug manufacture.
What drugs does Aqua Medica, S.A. de C.V. make?: 10 products are listed under Aqua Medica, S.A. de C.V. in the openFDA NDC Directory, most often as solution, concentrate; gel; powder, for solution. 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.