Strategic development of the enterprise is impossible without the development, registration and introduction of new types of products to the market.
Specialists of FF “Viola”
for the last 10 years
developed and put into production
20 medicines
100 names of parapharmaceutical products according
At the moment, FF “Viola” is actively continuing work on the development of the assortment:
10
as part of the development of the project for the production of drugs in the form of hard and soft gelatin capsules, more than 10 items were selected for development;
27
as well as about 27 names of promising medicines, medical devices, cosmetic products and dietary supplements in various forms (syrups, solutions, sprays, drops, gels, creams, ointments) for production at existing production facilities and under contract.
The selected positions belong to the new generation of modern generic drugs, their development is a rather complex, multi-stage and science-intensive process that requires certain knowledge, experience, personnel qualifications, as well as a material and technical base.
The main requirements for conducting pharmaceutical development are set out in the Instruction ST-N of the Ministry of Health 42-3.1:2004 “Medicinal products. Pharmaceutical development and related documents: pharmacopoeias (DFU, EP, USP), separate guidelines for technological processes, quality specifications, excipients and APIs, packaging materials, stability studies, validation and other industry domestic and international standards.
A team of scientific specialists usually works on the creation of the drug:
technologists (development of recipes and production technology, validation of technological and cleaning processes);
pharmacologists (preclinical studies
security profile);
clinicians (clinical tests of the effectiveness of the generic drug in comparison with the reference);
analysts and microbiologists (development and validation of analytical and microbiological methods of quality control of raw materials, semi-finished products and finished drugs in final packaging, stability studies).
- FF “Viola” conducts active work on the organization of its own R&D laboratory for the possibility of pharmaceutical development of a wide range of new generation drugs;
- within the framework of this project, it is planned to equip the research laboratory with modern technological and analytical equipment;
- with a separate staff of employees (including heads of directions for the development of various medicinal forms with scientific degrees of candidates and doctors of science);
- financing for the purchase of raw materials and consumables for the laboratory development of recipes, technologies, and quality control methods;
- experimental and industrial approval (release of experimental and industrial series with validation of processes and methods, study of stability to establish the expiration date).
The creation of such a laboratory will allow FF “Viola”
to carry out pharmaceutical development of drugs at a high scientific and research level for the possibility of providing modern approaches in complex treatment and meeting the constantly growing needs of the population for high-quality, safe and effective drugs of the new generation.