Mikart, LLC

Atlanta, Georgia, United States mikart.com

Overview

Mikart, LLC is a contract development and manufacturing organization (CDMO) that specializes in providing pharmaceutical services to the research and development sector. The company offers comprehensive services ranging from formulation development to commercial manufacturing, focused on oral solid and liquid dosage forms.

Therapeutic areas

CardiovascularCentral Nervous SystemGastrointestinal

API / Drug Master Files

Mikart, LLC holds 0 active (7 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.

  • LORCET PLUS TABLETSInactive1986-10-21
  • LORCET PLUS TABLETSInactive1986-07-24
  • LORTAB 7 TABLETSInactive1986-07-17
  • LORTAB TABLETSInactive1986-07-11
  • ACETAMINOPHEN AND HYDROCODONE BITARTRATEInactive1986-02-21
  • ACETAMINOPHEN & CODEINE PHOSPHATE TABS. 650/60Inactive1985-11-13
  • ATLANTA, GA. PLANT ON MARIETTA BLVD.Inactive1983-03-31

FDA compliance signals

3 FDA enforcement records linked to this company.

  • warning_letter2020-02-21

    FDA Warning Letter (drug product)

  • 4832019-01-18

    GMP Training Frequency

  • 4832019-01-18

    Quarantine Storage of Components

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