Is Polpharma Biologics S.A. FDA approved?

Polpharma Biologics S.A. holds 2 FDA-registered establishments 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 Polpharma Biologics S.A.'s drugs manufactured?

The FDA register lists Duchnice; Gdansk. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Polpharma Biologics S.A. make?

1 product is listed under Polpharma Biologics S.A. in the openFDA NDC Directory, most often as solution, concentrate. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Polpharma Biologics S.A.

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

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Registered sites: 2
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: Poland

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Polpharma Biologics S.A.	Ul. Spoldzielcza 4, Duchnice, Ozarow Mazowiecki 05-850, Poland (POL)	Analytical testing, Active ingredient (API) manufacture	3027094019849736088
Polpharma Biologics S.A.	ul. Trzy Lipy 3, Gdansk, 80-172, Poland (POL)	Analytical testing, Active ingredient (API) manufacture	3013195136850663938

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ranibizumab	solution, concentrate	82775-100BULK INGREDIENT

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Enquiry

Common questions

Is Polpharma Biologics S.A. FDA approved?: Polpharma Biologics S.A. holds 2 FDA-registered establishments 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 Polpharma Biologics S.A.'s drugs manufactured?: The FDA register lists Duchnice; Gdansk. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Polpharma Biologics S.A. make?: 1 product is listed under Polpharma Biologics S.A. in the openFDA NDC Directory, most often as solution, concentrate. 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.