Vantage Hemp Co. Submits Application for Brazil Market Entry

  • May 6, 2025

Greeley, Colorado, May 06, 2025 (GLOBE NEWSWIRE) — Vantage Hemp Co. (“Vantage” or “the Company”), a globally accredited cannabinoid extractor and manufacturer, has initiated its regulatory process with ANVISA, Brazil’s National Health Surveillance Agency, securing protocol numbers for its application of market authorization under the RDC 327/2019 framework and Good Manufacturing Practices Certification (CBPF). This marks the formal start of Vantage’s regulatory engagement with Brazil and lays the foundation for the Company’s broader push into Latin America.

Through a joint application with a Brazilian partner, Vantage has applied for approval for its initial formulation under RDC 327/2019. The bridge framework sets out rigorous requirements for the manufacturing, importation, and commercialization of cannabinoid-based products before pharmaceutical registration becomes feasible. This unique opportunity allows companies to apply for a license without having mandatory clinical studies which are often a major hurdle in the commercialization of pharmaceutical products. Vantage is positioned to meet the needs of the aspiring Brazilian market, which demands stringent pharmaceutical-grade manufacturing and full transparency across all production processes.

Under the framework, companies must obtain Sanitary Authorization for each product, valid for five years, and adhere to strict quality and safety standards, including THC content limitations and mandatory physician prescriptions. ​As the largest healthcare market in Latin America and ranking sixth worldwide for drugs and pharmaceuticals, Brazil offers significant growth potential for cannabinoid-based therapies.

As a mandatory step for compliant market entry, Vantage is pursuing CBPF certification from ANVISA, a requirement for manufacturing, importing, or distributing health-related products in Brazil. Backed by global compliance credentials such as WHO GMP, ICH Q7, and TGA PIC/S, Vantage is well-equipped to meet Brazil’s regulatory standards, solidifying its role as a trusted, capable partner in the country’s healthcare sector.

“Brazil represents an opportunity to support a large patient population. As a manufacturer, our goal is to empower companies in the region by providing compliant, scalable solutions,” says Deepank Utkhede, Chief Operating Officer at Vantage. “While some companies avoid or exit international markets due to compliance hurdles, we’re doubling down on our global expansion strategy, and we’re committed to doing it right.”

Following the receipt of protocol numbers, Vantage awaits ANVISA’s review and scheduling of a site audit. The Company continues to invest in regional market readiness and client partnerships, confident that its regulatory-first approach will translate to long-term commercial success. Companies looking to register cannabinoid products in Brazil under RDC 327/2019 are encouraged to contact Vantage for manufacturing and regulatory partnership opportunities.

About Vantage Hemp Co.
Colorado-based Vantage Hemp Co. extracts and processes cannabinoids from industrial hemp, as well as formulates and manufactures finished products with the extracted ingredients. 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. For more information, visit www.vantagehemp.com.

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