MannKind Corporation

Danbury, Connecticut, United States mannkindcorp.com

Overview

MannKind Corporation is a biopharmaceutical company specializing in the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes. Their flagship product, Afrezza, is an inhalable insulin used to control high blood sugar in adults with diabetes. The company is dedicated to advancing a pipeline of innovative treatments to manage chronic and debilitating conditions.

Therapeutic areas

DiabetesPulmonary diseases

API / Drug Master Files

MannKind Corporation holds 2 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

  • TREPROSTINIL INHALATION POWDERActive2018-10-17
  • AFREZZA® INHALATION POWDER AND AFREZZA® INHALERActive2014-10-15
  • INSULIN, HUMAN (RDNA HUMAN INSULIN) HMR 4006Inactive2003-03-26

FDA compliance signals

3 FDA enforcement records linked to this company.

  • warning_letter2018-10-05

    FDA Warning Letter (drug product)

  • 4832013-05-17

    Actual vs. theoretical yields not determined

  • 4832013-05-17

    Extent of discrepancy, failure investigations

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