Overview

Impax Laboratories, LLC is a pharmaceutical company based in the United States that develops, manufactures, and markets bioequivalent and brand-name pharmaceuticals. It is a subsidiary of Amneal Pharmaceuticals LLC following their merger. The company focuses on providing therapies for central nervous system disorders and other conditions.

Core services & business areas

Pharmaceutical ManufacturingRegulatory AffairsProduct DevelopmentQuality Assurance

Therapeutic areas

Central Nervous SystemParkinson's DiseaseEpilepsyMigraine

FDA compliance signals

6 FDA enforcement records linked to this company.

  • recall — Class I2016-12-28

    Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

  • recall — Class II2016-04-27

    Failed Impurities/Degradation Specifications

  • recall — Class II2016-04-27

    Failed Impurities/Degradation Specifications

  • recall — Class III2016-04-20

    Labeling: Incorrect or Missing Lot and/or Exp. Date

  • recall — Class III2016-04-20

    Labeling: Incorrect or Missing Lot and/or Exp. Date

  • warning_letter2011-05-31

    FDA Warning Letter (drug product)

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