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
Active pharmaceutical ingredients supplied
Substances Roxane Laboratories, Inc. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
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 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..
- recall — Class II2017-02-01
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
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