Is Saneca Pharmaceuticals a.s. FDA approved?

Saneca Pharmaceuticals a.s. holds 1 FDA-registered establishment in Slovakia. 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 Saneca Pharmaceuticals a.s.'s drugs manufactured?

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

What drugs does Saneca Pharmaceuticals a.s. make?

6 products are listed under Saneca Pharmaceuticals a.s. in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Saneca Pharmaceuticals a.s.

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

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Registered sites: 1
Active NDC listings: 6
Live patents: 0
Countries: 1
Base: Slovakia

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Saneca Pharmaceuticals a.s.	3345/100 Nitrianska, Hlohovec, Slovakia 92027, Slovakia (SVK)	Active ingredient (API) manufacture	3011324289367177816

Catalogue

Drug listings by form and route

6 active NDC listings: 6 bulk ingredient. By marketing category: BULK INGREDIENT 5, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage form	NDCs
powder	6

Route	NDCs

Labeller name on the listing	NDCs
saneca pharmaceuticals a.s.	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Nalbuphine Hydrochloride	powder	82105-006BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Naloxone Hydrochloride	powder	82105-005BULK INGREDIENT
-	Naltrexone	powder	82105-003BULK INGREDIENT
-	Naltrexone Hydrochloride	powder	82105-004BULK INGREDIENT
-	Pimobendan	powder	82105-001BULK INGREDIENT
-	Pimobendan	powder	82105-002BULK INGREDIENT

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Common questions

Is Saneca Pharmaceuticals a.s. FDA approved?: Saneca Pharmaceuticals a.s. holds 1 FDA-registered establishment in Slovakia. 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 Saneca Pharmaceuticals a.s.'s drugs manufactured?: The FDA register lists Hlohovec. Registered operations: active ingredient (API) manufacture.
What drugs does Saneca Pharmaceuticals a.s. make?: 6 products are listed under Saneca Pharmaceuticals a.s. in the openFDA NDC Directory, most often as powder. 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.