For a short period of time, Farmak has transformed from a chemical and technological plant into an innovative company – leader of the industry. Thanks to quality and innovations, we have been retaining leadership for over eight years. And we really have something to be proud of. We managed to build European production facilities here, in Ukraine. We are ready to share experience with domestic companies on how to do business in Ukraine according to European standards. Our distinctive feature is that we not only follow the innovations, but localize and adapt them here, in Ukraine, at our own manufacturing sites. To Your attention TOP-10 innovations of “FARMAK”
1. Global studies of a generic molecule. This is an original molecule of the Soviet school. Farmak has invested in international studies of the evidential base and evidence of efficacy on various models.
2. Global studies of a generic medicine Efial.This is an original molecular complex of biological origin based on liposomal forms enhancing the penetration of the active substance. Launch of the product is scheduled for 2019.
3. Insulin production based on Lilly (USA) technology – «Farmasulins».. These are the first American pharmaceutical technologies in Ukraine. Farmak is the world’s second company to receive the cartridge manufacturing technology, which is a set of complex knowledge in mechatronics and precision.
4. Bioequivalence studies.. Complex innovation. Implementation of this project has taken 10 years. This is the proof standard for therapeutic replaceability. Farmak has transferred the old nomenclature into a new formulation to achieve the criteria of therapeutic similarity. To that end, a pilot laboratory has been constructed, in which processes are modeled, optimized, and scaled. Product with continuously reproducible and well-established target profiles are transferred to the industrial scale.
5. Use of biotechnology.This is forward-thinking work. Each second new drug registered in the world is of biological or biotechnological origin. To retain its positions in the future, Farmak develops competencies in this direction, studies genetic engineering, biosynthesis, purification, description, and regulatory strategy in biosimilarity. Now the Company undergoes validation of technologies of recombinant synthesis of several active substances. In case of positive results, a decision on further investments in industrial-scale production will be made.
6. Proprietary APIs manufacturing.In 2015, the Company launched APIs production facilities in Shostka. Investments in this project amounted to $ 39 million. Farmak already has 20 proprietary substances in its portfolio and more than 20 are planned for years to come. The Company invests in its own production being in line with pharmaceutical standards and accounting for environmental aspects. Laboratories have been upgraded, and new approaches to synthesis (multistage synthesis, flow technologies in synthesis) have been used.
7. Manufacturing of radiocontrast agents.This is Farmak’s landmark product. 12 years ago, the Company accepted an offer from European partners for development and manufacturing, according to the European requirements, of the radiocontrast drug Magnegita. Farmak has rebuilt the core processes and completely adapted to new regulatory requirements. The product was successfully launched on the European market, and today we produce another product, Dotagita, under this model. This is the first experience of full-cycle contractual product launch for the European market: from development according to ICH standards to manufacturing according to EU GMP requirements. Currently, Farmak has taken for development of several other breakthrough products in this segment, including the development and manufacturing of substances.
8. State-of-the-art R&D laboratories.. Transformation from plant laboratories to intelligent clusters hosting processes for creation and optimization of new technologies, integrating quality with the use of modern analytical equipment. Currently, Farmak employes 35 candidates and doctors of sciences. This is a testing site, a platform for design and modeling of manufacturing processes.
9. Horizon 2020 Grant Programs.Since 2017, Farmak has been participant of two Horizon 2020 programs, VAHVISTUS and ORBIS, in Research and Innovation Staff Exchange (RISE). This is a unique opportunity to get acquainted with new developments of scientific laboratories of EU countries.
10. Farmak technopark.Farmak is 7 hectares of concentrated innovations and technologies, which form the arsenal of the modern pharmaceutical industry. The Company has evolved from a production site to an industrial park hosting key innovative and production technologies. Process optimization and transition to more sophisticated technologies is planned for the future. This is also a beneficial location for collaboration with the most advanced and intelligent talents.