Is Mannkind Corporation FDA approved?

Mannkind Corporation 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 Mannkind Corporation's drugs manufactured?

The FDA register lists Danbury, CT. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Mannkind Corporation make?

10 products are listed under Mannkind Corporation in the openFDA NDC Directory, most often as powder, metered; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mannkind Corporation

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

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Registered sites: 1
Active NDC listings: 10
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Mannkind Corporation	1 Casper St, Danbury, Connecticut (CT) 06810-6903, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3005340341099981040

Catalogue

Drug listings by form and route

10 active NDC listings: 7 human prescription drug, 3 drug for further processing. By marketing category: BLA 7, EXPORT ONLY 3.

Dosage form	NDCs
powder, metered	6
kit	4

Route	NDCs
respiratory (inhalation)	7

Labeller name on the listing	NDCs
mannkind corporation	7
mannkind corporation	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AFREZZA	INSULIN HUMAN	powder, metered, respiratory (inhalation)	47918-874BLA
AFREZZA	INSULIN HUMAN	powder, metered, respiratory (inhalation)	47918-878BLA
AFREZZA	INSULIN HUMAN	kit, respiratory (inhalation)	47918-880BLA
AFREZZA	INSULIN HUMAN	powder, metered, respiratory (inhalation)	47918-891BLA
AFREZZA	INSULIN HUMAN	kit, respiratory (inhalation)	47918-898BLA
AFREZZA	INSULIN HUMAN	kit, respiratory (inhalation)	47918-902BLA
AFREZZA	INSULIN HUMAN	kit, respiratory (inhalation)	47918-904BLA
-	INSULIN HUMAN	powder, metered	47918-178EXPORT ONLY
-	INSULIN HUMAN	powder, metered	47918-191EXPORT ONLY
-	Insulin Human	powder, metered	47918-174EXPORT ONLY

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Enquiry

Common questions

Is Mannkind Corporation FDA approved?: Mannkind Corporation 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 Mannkind Corporation's drugs manufactured?: The FDA register lists Danbury, CT. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Mannkind Corporation make?: 10 products are listed under Mannkind Corporation in the openFDA NDC Directory, most often as powder, metered; kit. 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.