Overview

Mylan is a pharmaceutical company headquartered in Canonsburg, United States, founded in 1961, with over 10,000 employees.

Core services & business areas

Pharmaceutical ManufacturingRegulatory AffairsQuality Assurance

API / Drug Master Files

Mylan holds 0 active (2 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.

  • MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF TRIFLUOROTHYMIDINE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.Inactive1996-06-20
  • MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PUERTO RICO.Inactive1987-08-17

FDA compliance signals

5 FDA enforcement records linked to this company.

  • recall — Class II2017-02-01

    Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

  • recall — Class II2017-02-01

    Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

  • recall — Class II2017-02-01

    Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

  • recall — Class II2017-02-01

    Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

  • recall — Class II2012-12-05

    Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

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