Suppliers / Mannkind

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.

1
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Molecule Regulators Docs
Treprostinil US FDA 1

Also appears on these molecule pages

Treprostinil finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 3 1
DMP (NO) 3 None
ANVISA (Brazil) None 1

Questions about Mannkind

Does Mannkind hold a US DMF or a CEP?
Mannkind holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Mannkind FDA-registered?
One site operated by Mannkind carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Mannkind's last inspection go?
The most recent inspection on record closed on 4 November 2025 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Mannkind manufacture?
2 registered sites are on record, in United States (Danbury and Danbury). Every site is listed on this page with the register it came from.
What does Mannkind make?
1 molecule is on record against Mannkind, including Treprostinil. Each links through to that molecule's full manufacturer list.
Which regulators recognise Mannkind's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was NAI, on 4 November 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates