Is Haupt Pharma Inc. FDA approved?

Haupt Pharma Inc. holds 1 FDA-registered establishment in Italy. 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 Haupt Pharma Inc.'s drugs manufactured?

The FDA register lists Borgo San Michele. Registered operations: analytical testing, finished drug manufacture, packaging.

Haupt Pharma Inc.

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

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

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Haupt Pharma Latina SrlRegistrant: Haupt Pharma Inc.	STRADA REGIONALE 156 DEI MONTI LEPINI, Borgo San Michele, Latina 04100, Italy (ITA)	Analytical testing, Finished drug manufacture, Packaging	3007687501338690598

Neighbours

Registered in the same town

Janssen Research & Development, L.L.C.Borgo San Michele, ITA

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Enquiry

Common questions

Is Haupt Pharma Inc. FDA approved?: Haupt Pharma Inc. holds 1 FDA-registered establishment in Italy. 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 Haupt Pharma Inc.'s drugs manufactured?: The FDA register lists Borgo San Michele. Registered operations: analytical testing, finished drug manufacture, packaging.

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.