The developing of pharmaceutical products as well as analytical methods for quality control and stability testing are carried out by the highly qualified staff of Sopharma R&D Department.
For the purposes of development, the experimental technological and analytical laboratories have the necessary technological equipment for pilot preparation of pharmaceutical products and modern analytical equipment for their testing and control.
Pharmaceutical development activities of Sopharma are in compliance with all currently applicable scientific guidelines and regulations.
Generic drug files are generally not required to be supported by own non-clinical and clinical studies and refer to safety and efficacy data of the innovator product. But the manufacturer of generic drugs must demonstrate that their products are bioequivalent with the reference medicinal product. For oral formulations this could be demonstrated via bioequivalence study, where the rate and extend of absorption are measured. The generic formulation must deliver to a patient's bloodstream the same amount of active substance during the same time as the innovator drug.
The highly qualified experts of Sopharma AD are in charge of this phase of product development. Bioequivalence studies are entrusted to organizations, engaged in the business of providing professional services to assist the development of pharmaceutical products. These trials are conducted in compliance with the study protocol, the ethical principles that have their origins in the Declaration of Helsinki, the ICH/GCP Guideline and the applicable national and international legislation. Sopharma AD develops qualitative, safe and efficient medicines.