IMPLEMENTATION OF THE TECHNOLOGY OF OBTAINING AFI VALIDOL TO AN ALTERNATIVE PRODUCTION SITE THROUGH INTERNAL TRANSFER WITHIN THE IMPORT SUBSTITUTION PROJECT

Abstract

Today JSC “Farmak” is a leader not only in the production of GLS in Ukraine, but also in the industrial production of API. The product portfolio of Farmak JSC includes 26 APIs of its own production, of which 21 substances are synthetic APIs of the full production cycle.Validol-based drugs are well proven, often used as a sedative and recommended as an anti-anginal agent.Today, the pharmaceutical market of Ukraine with medicines based on Validol is represented by 3 dosage forms from 5 manufacturers.Since currently there are not enough producers of this substance, the expansion of its production is promising.Therefore, the goal of our work was to analyze and systematize modern approaches to the transfer of technologies for the production of substances already on the market from one production site to another.The application of the specified approaches in the implementation of the technology of obtaining AFI Validol at an alternative production site within the framework of the import substitution project. The object of the study was the transfer of Validol AFI technology from one production site to another. The technology was successfully replicated at two sites – transmitting and receiving. At the transmitting site, work was carried out according to the approved technological instructions (TI), for the receiving site, new TIs were developed by adapting the technological parameters to the selected equipment of the receiving site, the determined critical parameters of the technological equipment and of the technological process. The parameters of the technological process, established during the transfer, have a greater economic effect after the Validol AFI has worked at the receiving site. Reproduced at another production site, the technology for obtaining the Validol substance is able to ensure obtaining a product of the proper quality, in accordance with the defined target profile of the quality of the substance, without using the reprocessing stage.