Is ZAKLADY FARMACEUTYCZNE POLPHARMA S A FDA approved?

ZAKLADY FARMACEUTYCZNE POLPHARMA S A holds 1 FDA-registered establishment in Poland. 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 ZAKLADY FARMACEUTYCZNE POLPHARMA S A's drugs manufactured?

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

What drugs does ZAKLADY FARMACEUTYCZNE POLPHARMA S A make?

6 products are listed under ZAKLADY FARMACEUTYCZNE POLPHARMA S A 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.

ZAKLADY FARMACEUTYCZNE POLPHARMA S A

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: Poland

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ZAKLADY FARMACEUTYCZNE POLPHARMA S A	Ul. Pelplinska 19, Starogard Gdanski, Pomorskie 83-200, Poland (POL)	Active ingredient (API) manufacture	3002807920422195139

Catalogue

Drug listings by form and route

6 active NDC listings: 6 bulk ingredient. By marketing category: BULK INGREDIENT 6.

Dosage form	NDCs
powder	6

Route	NDCs

Labeller name on the listing	NDCs
zaklady farmaceutyczne polpharma s a	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ACETAZOLAMIDE	powder	12658-0359BULK INGREDIENT
-	ACETAZOLAMIDE	powder	12658-0556BULK INGREDIENT
-	APIXABAN	powder	12658-0440BULK INGREDIENT
-	PIMAVANSERIN TARTRATE	powder	12658-0594BULK INGREDIENT
-	SILDENAFIL CITRATE	powder	12658-0483BULK INGREDIENT
-	TADALAFIL	powder	12658-0439BULK INGREDIENT

Compare

Comparable companies in Poland

NOBILUS ENT TOMASZ KOZLUK1 site · 3 NDC
NARODOWE CENTRUM BADAN JADROWYCH1 site · 1 NDC
Polpharma Biologics S.A.2 sites · 1 NDC

Enquiry

Common questions

Is ZAKLADY FARMACEUTYCZNE POLPHARMA S A FDA approved?: ZAKLADY FARMACEUTYCZNE POLPHARMA S A holds 1 FDA-registered establishment in Poland. 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 ZAKLADY FARMACEUTYCZNE POLPHARMA S A's drugs manufactured?: The FDA register lists Starogard Gdanski. Registered operations: active ingredient (API) manufacture.
What drugs does ZAKLADY FARMACEUTYCZNE POLPHARMA S A make?: 6 products are listed under ZAKLADY FARMACEUTYCZNE POLPHARMA S A 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.