The generic drug development and consistency evaluation - Guangzhou Lanning Biotechnology Co. LTD

Pharmaceutical research of generic drugs is mainly divided into API research and preparation research. The company focuses on API research business. Pharmaceutical research services include formulation, process, quality and stability research of pharmaceutical products, production of pharmaceutical impurities and quality consistency evaluation. The research and innovation of API impurities can achieve the same quality and efficacy of generic drugs and original drugs, and realize the substitution of original drugs.
The consistency evaluation of generic drugs is mainly based on the study of the prescription and quality of the original developed agent, and the study of the key quality attributes of excipients and preparations (indicators related to safety and effectiveness, such as content, related substances, pH, stability, etc.), so as to replace the original developed drug (imported from the original developed drug), so that the developed generic drug can achieve the same quality and efficacy as the original developed drug.