The production of pharmaceutical substances (API) is carried out on the basis of the License of the Ministry of Industry and Trade of Russia and its concordance with the Rules of Good Manufacturing Practice (GMP) is confirmed by the Conclusion.
Pharmaceutical substances are registered by the Ministry of Health of Russia and the requirements to it are defined in the Pharmacopeia articles of the enterprise (FSP). Components for dietary supplements and food additives (dry and thick extracts) are produced in accordance with the Technical Conditions registered in Ros Accreditation, they have a Declaration of Conformity. Finished products intended for retail sale made on the basis of dry extracts were examined at the Institute of Nutrition of the Russian Academy of Medical Sciences and received Certificates of State Registration in Russian Federal Consumer Rights Protection and Human Health Control Service.
Ecological products of healthy nutrition, with the quality confirmed by the European Eco Certificate has the EAEC Declaration of Conformity. These products are imported into the territory of the Russian Federation in accordance with applicable customs regulations.
There is the opportunity to mix extracts from various herbal raw materials in a calculated ratio at the drying stage as well as supplement of associated components. It allows you to receive products with specified characteristics for the active and associated components.
The equipment at the spray drying stage allows granulating extracts with the formation of non-dusting powders with a particle size of up to 300 microns. Granulation improves the consumer properties of the extracts in relation of controlling bulk density which allows to achieve the necessary flowability, solubility during technological operations
API active pharmaceutical ingredients, in the shape of dry and spissum extracts manufactured by our company are supplied to almost all pharmaceutical plants in Russia which produce preparations based on herbal components.
The manufacturing process includes the stages of extraction, concentration, filtration, drying, mixing / sieving and packaging. These process steps are validated in PV format. A validation procedure was also performed for the equipment, including DQ, IQ, OQ, and PV. Production stages are indicated by status labels, process parameters are continuously monitored and compliance with the specifications of the initial, intermediate and final products is recorded in the dossier for the series of the finished product.
Dry and spissum extracts out of plant materials are used as components for food products (teas, drinks, cereals), cosmetics and dietary supplement.
The technological process of production is carried out on modern equipment in accordance with the regulations Process parameters provide the maximum preservation of biologically active components in the extract. Microbiological purity of the product is ensured by the input control of plant materials and the choice of temperature-time parameters of extraction and concentration