API & FDF Experimental Producton
DEVELOPMENT OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED DOSAGE FORMS
Chemical Diversity Research Institute at ChemRar High-Tech Center develops technologies for the production of modern high-tech generics and original medicines, produces pilot batches of medicines, as well as provides services for the technology transfer of the experimental prototype technologies to the production site.
Development of technologies for the production of active pharmaceutical ingredients (API):
- Development and validation of the synthesis scheme, optimization of the technological process, production of pilot standard (repeatable) batches of API;
- Development of the draft Manufacturer’s Finished Product Monograph (FSP project), development and validation of specifications for analytical methods;
- API stability study during storage, API shelf life determination;
- Development of laboratory and industrial regulations for API manufacturing;
- Production and quality control of API prototype samples;
Development of technologies for the production of finished dosage forms (FDF):
- Development of composition and technology for FDF production the rationale for the selection, qualitative and quantitative composition of excipients, optimization of the production process;
- Development of the Manufacturer’s Finished Product Monograph (FSP project) for FDF, the rationale for the specifications and validation of analytical methods;
- FDF stability study during storage, FDF shelf life determination;
- Development of laboratory and industrial regulations for FDF production;
- Production and quality control of FDF prototype samples;
Technology transfer to the manufacturing site at the Customer’s choice.
Development of regulatory documents and registration dossiers and obtaining a marketing authorization in Russia.