NetworkNewsWire Editorial Coverage: The U.S. pharmaceutical industry is pocked with pitfalls that make it difficult for the development of cannabis-based drugs. To receive FDA approval, drug manufacturers must produce a consistent, pharmaceutical-grade product. Drug researchers with cannabis-based candidates are largely dependent on cannabis producers to access their drug raw materials. And therein lies the issue. The cannabis production sector has had its share of product recalls, and is saddled with pricey cost of commercial cultivation. The roadblocks are considerable – from legal and execution standpoints – making these efforts not quite impossible but certainly, currently, difficult. Canada-based biopharmaceutical company InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF) (IMLFF Profile) is taking these challenges head-on, and has broken new ground with an innovative, proprietary biosynthesis process that reliably creates pure cannabinoids. This process is capable of making any of the 90+ individual cannabinoids, under strict quality control resulting in >95% purity with no pesticides, and in a consistent fashion – factors that current plant growing methods of production cannot accomplish. Biosynthesized product with consistently high purity and quality poses a considerable advantage over the medical marijuana used by companies like CanniMed Therapeutics, Inc. (TSX: CMED) (OTC: CMMDF) (FRA: 0GB), which cultivates its own cannabis for its product pipeline. Any biotech company seeking to develop cannabinoid-based drugs could benefit from InMed’s unique approach. Currently, these biotech companies are dependent on growers like Aurora Cannabis, Inc. (TSX: ACB) (OTCQX: ACBFF), Canopy Growth Corp. (TSX: WEED) (OTC: TWMJF) and Aphria, Inc. (TSX: APH) (OTC: APHQF) to supply the raw flower or specific cannabinoid extracts needed, albeit only a few cannabinoids can be economically extracted from the plant. Such extracted product may not have the purity or consistency required to qualify as an FDA-approved pharmaceutical ingredient.
The extraction techniques from plant-growing operations are subject to high fluctuation in drug concentration, as flowers from the same marijuana plant display high fluctuations in drug composition. A key factor in receiving formal drug approval from regulatory authorities includes product consistency, which may be one reason the FDA, to date, has never approved a botanically-derived marijuana drug. A few synthetic cannabinoid-based drugs have, however, been approved by the FDA (http://nnw.fm/dyD4o), and experts believe marijuana’s only future as a medicine in the U.S. is through its isolated, pure cannabinoid components and their synthetic counterparts.
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