Two CBD Drug Master Files Submitted to the Food and Drug Administration

Colorado-based Vantage Hemp Co. announced today that it submitted a Drug Master File (DMF) for its cannabidiol (CBD) isolate to the Food and Drug Administration (FDA), having submitted one for its CBD distillate in 2022 (1).

“Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products,” stated the FDA website (2).

“Drug Master Files move the CBD industry forward with professionalism and legitimacy,” said Deepank Utkhede, Vantage’s Chief Operating Officer (1). “This is a significant milestone for our company. We believe that a commitment to consistency, quality, and cGMP compliance will help pave the way for greater regulatory clarity in the industry.”

With large-scale extraction facilities, Vantage Hemp Co. reportedly produces current good manufacturing practice (cGMP)-compliant CBD extracts including full-spectrum oil, distillate, and isolate.

References

1. https://www.vantagehemp.com/2023/04/03/vantage-hemp-co-submits-drug-master-file-for-cbd-isolate-to-the-u-s-food-drug-administration/
2. https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs