Pharmaceutical-grade CBD producer positions itself as a transparent partner to both clients and regulatory bodies
Greeley, Colorado, April 28, 2022 (GLOBE NEWSWIRE) — Vantage Hemp Co. (“Vantage” or the “Company”), further solidifies its position as an industry leader by its announcement of a Drug Master File (DMF) submission for its hemp-derived cannabidiol (CBD) distillate to the US Food & Drug Administration (FDA). With this DMF, Vantage establishes itself as a transparent, reliable, and compliant partner to pharmaceutical companies formulating with its CBD active pharmaceutical ingredient (API).
High Quality Products
Vantage’s current and forthcoming DMF submissions are a clear promise of support to clients through all phases of drug development by delivering unparalleled API quality, which is a key performance indicator for all stakeholders – regulators, clients, and, most importantly, patients and consumers. Vantage’s production and manufacturing facilities comply with current good manufacturing practices (cGMP) including WHO GMP, ICH Q7 and FDA CFR 210/211, thus meeting both domestic and international standards for pharmaceutical products.
CBD Distillate Drug Master File and the FDA
“Our CBD Distillate Drug Master File is a testament to Vantage’s dedication to manufacturing the highest quality CBD API. Vantage exemplifies the breadth of knowledge, depth of collaboration, and attention to detail expected and required of an API producer,” said Vantage’s Chief Operating Officer, Deepank Utkhede. Vantage confidentially provides the FDA with all details on facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of CBD distillate that the regulator requires for approval of drug ingredient applications.
“As a tier-one ingredient partner, Vantage meets the quality, safety, efficacy, and reproducibility requested by regulatory bodies. Our DMF submissions help the company achieve its goal of expanding into the international pharmaceutical industry while validating the entire production chain,” adds Laura Eder, Vantage’s Director of Regulatory Affairs and Quality Assurance.