GMP: Good Manufacturing Practice: API Manufacturing
Active Pharmaceutical Ingredient (API) Manufacture
Following the initial processing of herbal products, active ingredients are extracted under GMP conditions to create a cannabinoid-rich oil containing approximately 50% cannabinoids. This oil can then undergo further refinement to remove impurities and concentrate the cannabinoid content.
The resulting Active Pharmaceutical Ingredients (APIs) are standardized, GMP-compliant ingredients that can be sold as wholesale products or formulated into various final product forms, including tinctures, tablets, capsules, and topical applications. These APIs serve as the foundational commodities in the cannabis industry and are often traded in large quantities, ranging from hundreds to thousands, or even tens of thousands of kilograms as part of supply and offtake agreements.
API manufacture and distribution are governed by specialized areas of Good Practices (GxP), ensuring that products meet the highest standards of quality and safety throughout their lifecycle.
Cannabis Active Pharmaceutical Ingredients (APIs)
- Granulated Standardized Dried Herbal Cannabis (10-20% cannabinoids)
- Raw Cannabis Oil (40-50% cannabinoids)
- Winterized Cannabis Oil (45-55% cannabinoids)
- Distillate (80-85% cannabinoids)
- Double Distillate (90-98% cannabinoids)
- Isolated Cannabinoids (99.0%-99.9% cannabinoids)
Medical Cannabis GxP: Good Practices for Medical Cannabis
- GAP: Good Agricultural Practice: Propagation and Cultivation
- GMP: Good Manufacturing Practice: Processing Herbal Products into Medicines
- GDP: Good Distribution Practice: Sales, Brokerage and Distribution
- GCP: Good Clinical Practice: Prescribing and Clinical Trials
- GLP: Good Laboratory Practice: Clinical Testing and Analytic Testing (Also covered by ISO)
- Rhizo Sciences Quality Statement for Medical Cannabis
Implementing GMP Practices at Hempex
At Hempex, our commitment to GMP standards is reflected in our manufacturing processes for all our products, including tinctures, oils, and other hemp extracts. We operate in FDA-certified food-grade facilities, ensuring that our manufacturing complies with rigorous GMP guidelines. Each batch of our products undergoes comprehensive quality control measures, including lab testing at accredited GLP ISO 17025 laboratories. This process guarantees that our products meet the highest standards of safety, potency, and purity before reaching our customers.
By integrating GMP practices into our API manufacturing process, we ensure that our active ingredients not only meet regulatory standards but also provide consistent quality for our clients. Our APIs are used in various formulations, allowing us to supply high-quality cannabis-derived products that are both effective and compliant with industry regulations. This commitment to quality not only strengthens our brand reputation but also enhances customer trust in our products.
