Active Pharmaceutical Ingredient (API) Process
Seed & propagation material. Bassani Medical’s seeds are traceable and originate from plants that have been accurately identified in terms of genus, species, variety/cultivar/chemotype and origin.
Our seeds are feminised, genetics certified and sourced from leading suppliers.
Our mother stock. Bassani Medical guarantees healthy mother plants by selecting the best individual female plants which are free from pests and diseases. Good cultivation practices limit the ageing of our mother plants.
Adulteration is avoided by controlling the presence of varied species, varieties, or different plant parts during the entire production process.
Cloning. We take clippings from our Mother Plants and allow them to become independent healthy clones. The rooting process takes between 2-4 weeks.
Growing & harvesting. Once the clones sprouted their own roots and leaves, they are transferred to the vegetation station. Our plants will start flowering after 8 weeks. Harvesting starts once the flowers have matured and have reached the best possible quality for the proposed use.
Our primary processing includes cutting, debugging, wet trimming and air-drying. All these processes conform to national and global regulations and are conducted as soon after harvesting as possible. The flower will be processed strictly according to EU-cGMP conditions and procedures. The material will at this stage be transferred to Bassani Medical world class API processing facility.
API Raw Processing. The actives will be extracted from the flower, using recently patented technology to extract 100% of the crude API from the flower.
Processing of Crude API. The crude API will be transferred to our “best in its class” final processing area. Here the various Alkaloids (Natural API’s) will be separated using new Column Chromatography technology to ensure a 100% pure API.
Testing and Storage – The API in its pure form will be tested according the USP and BP testing specifications and samples. Retained samples will be drawn for our Stability Studies Programme and test results will be recorded per our Drug Master Files.
Drug Master File Registration. Bassani Medical will register its DMF’s in the US as carried out through drug master file process (type-1&2), while in EU, the registration will be done by filing of active substance master file (ASMF) for support of both our New Drug Application (NDA) and our Abbreviated New Drug Applications (ANDA) Partners.
International Distribution of Final API’s. Bassani Medical will utilize international partners in the US as well as Europe and the far East to distribute its API’s.