A Global Shift for Manufacturers: The International Demand for cGMP Compliance

Meeting global demand while adhering to regional regulatory needs

The global cannabidiol market is poised to grow by $29.91 billion during 2021-2025, progressing at a CAGR of 26.93% during the forecast period.1 Europe, North America, Latin America, Asia Pacific, and the Middle East comprise the regions within the global CBD marketplace. So what does that mean for manufacturers?

International regulators are becoming more favorable towards CBD and for manufacturers, meeting cGMP compliance is a requirement. In Australia, all current CBD products are to be manufactured compliant to a pharmaceutical process. Additionally, the international landscape has seen many Latin American governments taking steps to create legal markets for CBD products, however, companies must ​comply with extensive GMP requirements. As the cannabinoid industry matures, domestic and international regulations will define manufacturing and quality requirements, only allowing manufacturers who meet these regulations to market products.

The CBD market within the outlined regions can be segmented into the following profiles: pharmaceuticals, natural health products/dietary supplements, cosmetics/topicals, and food and ingredients. In 2020, pharmaceuticals accounted for the highest revenue share of 42.8%.2 As clinical trials with CBD products continue to demonstrate value in areas of unmet medical need, Vantage Hemp Co. provides international partners with cGMP compliant APIs and clinical trial dosage formats to support their pursuit of regulatory approvals.

Companies that look to meet global manufacturing demand have a requirement to be regulatory compliant across all regions of interest. The international pharmaceutical industry demands cGMP compliance to partner with a manufacturer. Equally, the natural health/dietary supplements, cosmetics and food and ingredients segments look for a manufacturing partner who understands the unique differences for each region they sell products into.

Today, a “one size fits all” manufacturing approach is no longer relevant or acceptable. International clients are requiring compliance, greater variation in products, competitive manufacturing cost, delivery reliability, and more types of after-sales service—requirements Vantage consistently meets.

“We believe Vantage has what it takes to go global and we’ve taken a metered, strategic approach to execution. We’re prepared to overcome challenges and aren’t afraid to move forward and move forward quickly,” said Christian Santi, Director of Sales at Vantage.

“When you expand globally, each country you reach comes with a new set of regulations,” added Santi. “What works in your home country may not work in another.”

 

1 https://www.researchandmarkets.com/reports/5510825/global-cbd-market-2021-2025?utm_source=GNOM&utm_medium=PressRelease&utm_code=xq3s7r&utm_campaign=1639800+-+Worldwide+CBD+Industry+to+2025+-+Rising+Popularity+of+CBD+Oil+is+Driving+Growth&utm_exec=jamu273prd

2 https://www.grandviewresearch.com/industry-analysis/cannabidiol-cbd-market

Darcie Moran

With pharmaceutical experience and an impressive decade-long career in the cannabis and hemp sector, Darcie is a well-rounded expert in ensuring top-notch quality standards. Her extensive knowledge spans seed to sale, cultivation, extraction, testing, quality assurance, compliance, and pharmaceutical practices. Darcie's diverse background allows her to bring a unique perspective to her role at Vantage. In addition to her expertise in quality management, Darcie has showcased her knowledge and skills in pharmaceutical audits and as a result, has positioned Vantage as a trusted and reliable partner for pharmaceutical and clinical study customers. Darcie also played a pivotal role in developing Vantage's Quality Management System (QMS) and has successfully scaled it to an electronic system. Through her innovative thinking and expertise, she has introduced enhancements like automation, streamlining the company’s processes. Darcie's contributions to the cannabis and hemp industry extend beyond her role at Vantage. As a member of the ASTM subcommittee for D37.02 Cannabis and Hemp Quality Management Systems, she actively shapes the future of quality standards in the industry. Her expertise and commitment to quality make her an invaluable asset to the committee and the industry as a whole.

No Comments

Sorry, the comment form is closed at this time.