Vantage pursues Drug Master Files with the FDA to support the quality and safety of its products
Greeley, Colorado, January 24, 2022 – Vantage Hemp Co. (“Vantage” or the “Company”), an industry-leading manufacturer of pharmaceutical-grade CBD products, today announced that the Company is in the final stages of preparing its Drug Master Files (DMF) for submission to the US Food & Drug Administration. The submissions align with Vantage’s pursuit of expanding within the pharmaceutical industry.
Vantage’s preparation for its DMF submissions emphasizes the Company’s confidence in the robustness and reproducibility of its established processes through an early entry into the pharmaceutical industry that is supported by Vantage’s expansion of its contract manufacturing services to domestic and global clients. The Company’s DMFs will house the information needed by the FDA when Vantage’s clients are applying for FDA approval of their drug product. The reference of Vantage’s DMFs by brand owners will ensure legal protection and communication consistency throughout the approval process.
“Vantage is eager to hopefully be one of the first CBD companies to file DMFs for all our ingredients. Our company has worked extremely hard to create an all-encompassing Quality Management System, qualify our equipment, and validate our processes to place our products on both accelerated and long-term stability for multiple zones. Vantage’s goal is to work with clients worldwide to help move the CBD industry forward with professionalism and legitimacy. The possibilities with hemp are just starting to be seen and it is exciting to see where those possibilities will lead us. This is one of the main reasons I pursued the CBD space after my time in the pharmaceutical industry,” said Laura Eder, Director of Regulatory Affairs and Quality Assurance at Vantage.
About Vantage Hemp Co.
With large-scale extraction facilities, Colorado-based Vantage Hemp Co. delivers pharmaceutical-grade GMP compliant CBD extracts (including full-spectrum oil, distillate and isolate) that companies can trust. Vantage’s contract manufacturing services offer a broad range of benefits as they operate with integrity and abide by stringent pharmaceutical-production standards to provide quality products to their partners.