Mannkind
United States 801 employees Updated 9 July 2026
Mannkind is a finished-dose manufacturer based in United States. It holds one active US drug master file. Its filings concentrate with US FDA and DMP (NO). Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 4 November 2025 as NAI.
2
registered plants
1 with an FDA FEI number
6
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 4 November 2025 NAI US FDA
- 6 August 2021 VAI US FDA
- 19 June 2018 NAI US FDA
- 17 May 2013 VAI US FDA
- 4 December 2009 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| DANBURY, United States | Not on file |
| Danbury, United States | 3005340341 |
What they file, and where
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 3 | 1 |
| DMP (NO) | 3 | None |
| ANVISA (Brazil) | None | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 4 November 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates