Is Purolite S.R.L. FDA approved?

Purolite S.R.L. holds 2 FDA-registered establishments across 2 countries. 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 Purolite S.R.L.'s drugs manufactured?

At registered sites in Romania, the United States. The FDA register lists Victoria; King of Prussia, PA. Registered operations: active ingredient (API) manufacture.

What drugs does Purolite S.R.L. make?

4 products are listed under Purolite S.R.L. 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.

Purolite S.R.L.

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

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Registered sites: 2
Active NDC listings: 4
Labeller names: 2
Live patents: 0
Countries: 2
Base: Romania

Authorisation

Registered operations

Active ingredient (API) manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Purolite S.R.L.	Str Aleea Uzinei, Nr. 11, Victoria, Brasov 505700, Romania (ROU)	Active ingredient (API) manufacture	3004201705645132416
Purolite LLC	3700 Horizon Drive, King of Prussia, Pennsylvania (PA) 19406, United States (USA)	Active ingredient (API) manufacture	3030504602119109608

Catalogue

Drug listings by form and route

4 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 4.

Dosage form	NDCs
powder	4

Route	NDCs

Labeller name on the listing	NDCs
purolite llc	3
purolite llc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	CHOLESTYRAMINE	powder	68444-0001BULK INGREDIENT
-	SODIUM POLYSTYRENE SULFONATE	powder	68444-0002BULK INGREDIENT
-	SODIUM POLYSTYRENE SULFONATE	powder	68444-0004BULK INGREDIENT
-	SODIUM POLYSTYRENE SULFONATE	powder	68444-0005BULK INGREDIENT

Neighbours

Registered in the same town

Childrens Hospital of PhiladelphiaKing of Prussia, PA

Compare

Comparable companies in Romania

Antibiotice SA1 site · 2 NDC

Enquiry

Common questions

Is Purolite S.R.L. FDA approved?: Purolite S.R.L. holds 2 FDA-registered establishments across 2 countries. 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 Purolite S.R.L.'s drugs manufactured?: At registered sites in Romania, the United States. The FDA register lists Victoria; King of Prussia, PA. Registered operations: active ingredient (API) manufacture.
What drugs does Purolite S.R.L. make?: 4 products are listed under Purolite S.R.L. 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.