Is Macco Organiques, S.r.o. FDA approved?

Macco Organiques, S.r.o. holds 1 FDA-registered establishment in Czechia. 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 Macco Organiques, S.r.o.'s drugs manufactured?

The FDA register lists Bruntal. Registered operations: active ingredient (API) manufacture.

What drugs does Macco Organiques, S.r.o. make?

30 products are listed under Macco Organiques, S.r.o. in the openFDA NDC Directory, most often as powder; crystal; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Macco Organiques, S.r.o.

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

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Registered sites: 1
Active NDC listings: 30
Labeller names: 3
Live patents: 0
Countries: 1
Base: Czechia

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Macco Organiques, S.r.o.	Zahradni 1938/46c, Bruntal, 79201, Czech Republic (CZE)	Active ingredient (API) manufacture	3003158142521632476

Catalogue

Drug listings by form and route

30 active NDC listings: 30 bulk ingredient. By marketing category: BULK INGREDIENT 30.

Dosage form	NDCs
powder	16
crystal	12
solution	2

Route	NDCs

Labeller name on the listing	NDCs
macco organiques, s.r.o.	17
macco organiques, s.r.o.	11
macco organiques, s.r.o.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	AMMONIUM SULFATE	powder	67706-0005BULK INGREDIENT
-	AMMONIUM SULFATE	crystal	67706-0010BULK INGREDIENT
-	CALCIUM CHLORIDE	powder	67706-0001BULK INGREDIENT
-	CALCIUM CHLORIDE	crystal	67706-0011BULK INGREDIENT
-	CALCIUM GLYCEROPHOSPHATE	powder	67706-0031BULK INGREDIENT
-	Calcium Chloride	crystal	67706-0017BULK INGREDIENT
-	MAGNESIUM CHLORIDE	powder	67706-0002BULK INGREDIENT
-	MAGNESIUM CHLORIDE	crystal	67706-0027BULK INGREDIENT
-	MAGNESIUM SULFATE	powder	67706-0006BULK INGREDIENT
-	MAGNESIUM SULFATE	crystal	67706-0026BULK INGREDIENT
-	MAGNESIUM SULFATE HEPTAHYDRATE	crystal	67706-0012BULK INGREDIENT
-	MAGNESIUM SULFATE HEPTAHYDRATE	powder	67706-0013BULK INGREDIENT
-	MAGNESIUM SULFATE HEPTAHYDRATE	crystal	67706-0020BULK INGREDIENT
-	Magnesium Chloride	crystal	67706-0018BULK INGREDIENT
-	Magnesium Sulphate	powder	67706-0019BULK INGREDIENT
-	POTASSIUM CHLORIDE	powder	67706-0003BULK INGREDIENT
-	POTASSIUM CHLORIDE	crystal	67706-0021BULK INGREDIENT
-	POTASSIUM NITRATE	powder	67706-0009BULK INGREDIENT
-	POTASSIUM SULFATE	powder	67706-0025BULK INGREDIENT
-	SODIUM GLYCEROPHOSPHATE	powder	67706-0024BULK INGREDIENT
-	SODIUM LACTATE	solution	67706-0029BULK INGREDIENT
-	SODIUM SULFATE ANHYDROUS	powder	67706-0004BULK INGREDIENT
-	SODIUM SULFATE ANHYDROUS	crystal	67706-0014BULK INGREDIENT
-	SODIUM SULFATE ANHYDROUS	powder	67706-0022BULK INGREDIENT
-	TRISODIUM CITRATE DIHYDRATE	powder	67706-0028BULK INGREDIENT
-	TRISODIUM CITRATE DIHYDRATE	solution	67706-0030BULK INGREDIENT
-	ZINC SULFATE HEPTAHYDRATE	powder	67706-0008BULK INGREDIENT
-	ZINC SULFATE HEPTAHYDRATE	crystal	67706-0023BULK INGREDIENT
-	ZINC SULFATE MONOHYDRATE	powder	67706-0007BULK INGREDIENT
-	ZINC SULFATE MONOHYDRATE	crystal	67706-0015BULK INGREDIENT

Compare

Comparable companies in Czechia

Teva Czech Industries s.r.o.1 site · 41 NDC
TAPI Czech Industries s.r.o.1 site · 32 NDC
CZECH-GEN, a.s.1 site · 11 NDC
Cayman Pharma s.r.o.1 site · 7 NDC
Contipro a.s.1 site · 2 NDC
VUAB Pharma A.S.1 site · 1 NDC
Synthesia, a.s.2 sites · 1 NDC
Synthon Pharmaceuticals, Inc.4 sites · 1 NDC

Enquiry

Common questions

Is Macco Organiques, S.r.o. FDA approved?: Macco Organiques, S.r.o. holds 1 FDA-registered establishment in Czechia. 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 Macco Organiques, S.r.o.'s drugs manufactured?: The FDA register lists Bruntal. Registered operations: active ingredient (API) manufacture.
What drugs does Macco Organiques, S.r.o. make?: 30 products are listed under Macco Organiques, S.r.o. in the openFDA NDC Directory, most often as powder; crystal; 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.