Is Mallinckrodt Hospital Products Inc. FDA approved?

Mallinckrodt Hospital Products Inc. holds 1 FDA-registered establishment in the United States. 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 Mallinckrodt Hospital Products Inc.'s drugs manufactured?

The FDA register lists Port Allen, LA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.

What drugs does Mallinckrodt Hospital Products Inc. make?

1 product is listed under Mallinckrodt Hospital Products Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mallinckrodt Hospital Products Inc.

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: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Mallinckrodt Manufacturing LLCRegistrant: Mallinckrodt Hospital Products Inc.	1060 Allendale Dr, Port Allen, Louisiana (LA) 70767, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging	2350054015322416

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Terlivaz	Terlipressin	injection, powder, lyophilized, for solution, intravenous	43825-200NDA

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Enquiry

Common questions

Is Mallinckrodt Hospital Products Inc. FDA approved?: Mallinckrodt Hospital Products Inc. holds 1 FDA-registered establishment in the United States. 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 Mallinckrodt Hospital Products Inc.'s drugs manufactured?: The FDA register lists Port Allen, LA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
What drugs does Mallinckrodt Hospital Products Inc. make?: 1 product is listed under Mallinckrodt Hospital Products Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution. 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.