Roxane Laboratories, Inc.
Overview
Roxane Laboratories, Inc. is a pharmaceutical company engaged in the development and production of generic medications. It operates as a subsidiary of Hikma Pharmaceuticals PLC, a global leader in the generic pharmaceuticals industry.
Therapeutic areas
API / Drug Master Files
Roxane Laboratories, Inc. holds 0 active (1 total) FDA Type II Drug Master File — 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.
- CHLORAMPHENICOLInactive1998-09-01
FDA compliance signals
2 FDA enforcement records linked to this company.
- recall — Class II2017-02-01
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
- recall — Class III2017-02-01
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
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