Vantage Hemp Co. is in the Final Stages of its DMF Submissions
24 January 2022 - 12:45PM
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 (DMFs) 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.
Christian Santi
Vantage Hemp Co.
720-663-6082
christian@vantagehemp.com
Brooke Russell
Marigold Marketing & PR
1-877-681-5541
brussell@marigoldpr.com