Is Purac Biochem B.V. FDA approved?

Purac Biochem B.V. holds 1 FDA-registered establishment in the Netherlands. 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 Purac Biochem B.V.'s drugs manufactured?

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

What drugs does Purac Biochem B.V. make?

1 product is listed under Purac Biochem B.V. in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Purac Biochem B.V.

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Purac Biochem B.V.	Arkelsedijk 46, Gorinchem, Zuid-Holland NL-4206 AC, Netherlands (NLD)	Active ingredient (API) manufacture	3002806633405232687

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	SODIUM LACTATE, L-	liquid	61157-010BULK INGREDIENT

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Common questions

Is Purac Biochem B.V. FDA approved?: Purac Biochem B.V. holds 1 FDA-registered establishment in the Netherlands. 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 Purac Biochem B.V.'s drugs manufactured?: The FDA register lists Gorinchem. Registered operations: active ingredient (API) manufacture.
What drugs does Purac Biochem B.V. make?: 1 product is listed under Purac Biochem B.V. in the openFDA NDC Directory, most often as liquid. 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.