Is Hepac B.V. FDA approved?

Hepac 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 Hepac B.V.'s drugs manufactured?

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

What drugs does Hepac B.V. make?

1 product is listed under Hepac B.V. 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.

Hepac 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
Hepac B.V.	Kieveen 18, Loenen GLD, 7371 GD, Netherlands (NLD)	Active ingredient (API) manufacture	3008821373415308287

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Crude Heparin	powder	57858-280BULK INGREDIENT

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Common questions

Is Hepac B.V. FDA approved?: Hepac 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 Hepac B.V.'s drugs manufactured?: The FDA register lists Loenen GLD. Registered operations: active ingredient (API) manufacture.
What drugs does Hepac B.V. make?: 1 product is listed under Hepac B.V. 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.