BSPG Laboratories is a manufacturer of clinical stage Cannabidiol located in the United Kingdom that produces a pure, natural CBD molecule, with no traces of THC.
BSPG presently has Medicines and Healthcare Products Regulatory Agency’s (MHRA) approval to manufacture an approved pharmaceutical grade ingredient (API). The API approval is for the compound Cannabidiol. This approval confirms the procedures and practices used are pharmaceutical grade and the ingredients manufactured are qualified for use in the manufacturing of therapeutic drugs for Humans, and Veterinarian products.
Any pharmaceutical company developing CBD-based finished pharmaceutical products for humans or animals could source the API from BSPG. Approval from MHRA has entitled BSPG to supply its isolated CBD to pharma companies in all of the countries that are part of the Mutual Recognition Agreement (MRA), which includes USA, Canada, Australia, EU, etc.
The worldwide market for CBD is estimated to be $2 Billion USD and growing. Clinical research is ongoing to validate the therapeutic uses of CBD to develop pharmaceutical drugs for human use. Indeed, the first Food and Drug Administration (FDA) approved CBD drug, Epidolex® was approved in June 2018, as an anti-seizure medication to treat two severe forms of epilepsy. That is just ONE of the potential nine indications presented above.
There are at least half a dozen more pharma companies working at their final phase of clinical studies and regulatory approvals to market this compound for different therapeutic claims. The ISSUE in this industry is, besides GW Pharmaceuticals, all of these companies are either using synthetic versions or do not have the ability to produce enough CBD extracted from natural plant sources to support their needs. Compared to synthetic CBD, CBD from natural plant sources are more readily synthesized by the body with fewer side effects.
Cannabidiol (CBD) is a phytocannabinoid, non-psychoactive molecule present in the Cannabaceae family of plants, and has been shown to have therapeutic benefits in a wide range of medical ailments including, but not limited to:
- Post Traumatic Stress Syndrome
- Chronic pain
- Multiple Sclerosis
- Addiction and Alcoholism
As stated in the Hemp Business Journal (www.hempbizjournal.com), the market size of CBD by the year 2020 will be $2.1 billion and is forecasted to be a $3 billion market by year-2021.
Further approval of any therapeutic drugs before 2020 would increase the market value by multiple folds to the proposed forecast. The market for API grade molecules is very large, as there is a scarcity and no oversupply in sight of API grade molecules.
An active pharmaceutical ingredient (API) is a biologically active ingredient used in the fabrication of finished pharmaceutical products (FPP). The facility that manufactures such an API ingredient must be inspected and approved by a regulatory body for their Good Manufacturing Practice (GMP) standards. BSPG has proudly acquired its cGMP certificate.
API or Compound
BSPG’s capabilities are not limited to CBD alone but can be extended to other Cannabinoid molecules such as THC, CBG, and CBN. All of these molecules are said to have their own distinct therapeutic benefits and potentially larger, if not similar, market valuations.
The pure isolate produced at BSPG has various market opportunities, including therapeutic drugs, clinical trials, recreational and vape products. To attain sustainable quality standards of a product throughout the life cycle, a GMP-grade CBD is required. Hence, every category of CBD-based products (recreational or medicinal) prefers to source CBD from facilities like BSPG.
Also, the drug development and clinical trials for all proposed indications of CBD require API, which creates a huge demand for the ingredient processed at BSPG. Moreover, the number of API suppliers in the market are insufficient to meet the demand for the CBD ingredient required for ongoing studies and commercial product development.