Oxcarbazepine is an important drug in treatment of epilepsy and related disorders. It is successfully applied to patients globally in a wide variety of presentations. Recent more stringent quality requirements and restrictions in global supply have led Archimica to develop a revised Drug Master File for the active pharmaceutical ingredient (API).
Archimica´s Oxcarbazepine API satisfies both the European and US Pharmacopoeia requirements.
Its revised process and testing controls all related impurities to the most modern standards in quality and manufacturing.
Our customers can select between a range of grades. Archimica offers standard crystalline grade, standard micronized grade and supplies customer-specific particle size micronized grades.
Archimica offers a supply security backed solution for the supply of Oxcarbazepine API, which is ideally suited for small volume up to 15 metric tons annual demands, and/or second source supply into our customers´ larger volume applications, due to Archimica´s fast ramp-up capability, allowing larger volumes in case of need. Archimica is excited to support the global supply into of this important drug with its modern and specific capabilities, to serve the continuity and supply to patients worldwide.