Alkaloids produces two grades on a commercial basis: non-micronized and micronized material.
The existing CEP has been amended and now includes the micronization step, hence the current version No. R1-CEP 2010-298-Rev 01 covers now both grades, micronized and non-micronized material. The revision also includes editorial updates and notifications. We believe this new version represents a significant improvement over the previous version and will support our customers with their drug product registrations.
The micronization step is done in-house. Importantly, the micronized material from Alkaloids does not require any special cooling during transportation or storage.