Overview
Mylan is a pharmaceutical company headquartered in Canonsburg, United States, founded in 1961, with over 10,000 employees.
Core services & business areas
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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