Labat Pharmaceuticals is poised to become a leader in cannabis-based Active Pharmaceutical Ingredients (API) and finished-form dosage for the complementary medicines market and pharmaceuticals markets. The company will register all its products in line with the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as outlined by the Department of Health (DoH) and the South African Health Products Regulatory Authority (SAHPRA). It is our intention to register Drug Master Files (DMFs) for these APIs in the United States and every other relevant country in the world. This will allow access to big pharma and ensure high value income streams for the business. The facility will thus be designed and operated according to United States Food and Drug Administration (FDA) guidelines.
Labat Cannabis SA has commenced the process of acquiring a SAHPRA-approved facility in Kwazulu-Natal. The facility has formulation clean rooms and with further investment the company’s capabilities will include:
The Facility will eventually employ in excess of 120 skilled to highly skilled employees. These will include Process Operators, Quality Control and Quality Assurance staff, Regulatory Affairs staff, Research and Development Staff and Administration and Warehousing staff. This facility will be run by Dr Renske Snyman (Chemistry PhD, BCOM Finance, MBA and Lighting Design Engineer). Dr Snyman has 20 years’ experience in the API industry with experience in operations and research and development.
For the CAMS market we will ensure that our purification process respects the phytochemical profile of the hemp plant, delivering a high concentration of CBD with a full array of terpenes and non-psychoactive CBD selected to enhance the plant’s natural benefits. With high-quality raw material inputs from our sister company, Labat Oriah Botanicals, we will produce cannabis extracts using state-of-the art supercritical fluid CO2 extraction technology. This process extracts the major cannabinoids (THC and CBD), as well as the minor cannabinoids, terpenes, and flavonoids that contribute to the overall medicinal value of medical cannabis, resulting in a highly-concentrated resin which can then be further purified using Chromatography Technology.
The pure cannabanoid APIs will specifically be targeted for supply to big pharma. We also produce CBD oil products with different ratios of CBD (THC free) in order to meet the unique medical needs of our customers. These oils we will offer in bottle form and ensuring that the maximum dosage of 20mg CBD daily is easily controlled.
We will also offer soft-gel capsules for the convenience, precise and discrete dosing solutions that they offer and for those interested in consuming their medical cannabis in pill form. Our soft-gels will be available in a variety of medicinal applications.
CBD products that don’t contain THC fall outside the scope of SAHPRA Controlled Substances Act, which means CBD products are legal to sell and consume if they don’t have any THC (Limit set by the DOH is less than 0.001%). If the THC level is above this limit it will be regarded as a schedule 4 drug and will therefore require a prescription.
Labat Pharmaceuticals, with its world-class equipment and technology will have a significant advantage as we will be able to purify to the prescribed limit of 0.001%. CBD products, including CBD oil, are becoming more socially acceptable and increasingly popular. In 2016, Forbes reported that CBD products are expected to be a $2.2 billion industry by 2020.
Our chemists will have years of experience in the pharmaceutical extraction and purification of broad-spectrum natural products and we will use the latest innovative technologies in a high-efficiency laboratory, employing the most advanced purification and analytical techniques to create the highest quality product. Our analytical platform will include: High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC) for cannabinoids, mass spectroscopy to test for pesticides and contaminants, microbiological and multi-residual analysis.