Drug Master File

Our Product is a bio-active proteins classified as a Active Product Ingredient entering in a drug composition.

Our Drug Master File (DMF) contains a complete information on the API ‘s chemistry, manufacture process , stability, purity, impurity profile, packaging, and the cGMP status. All those informations are presented in the Applicant part or the Restricted Part. This drug master file can be submitted to the appropriate authorities in the intended drug market for an easy use of avidin in the customers applications.