Recently, Sichuan Vital Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Tibet AIM Pharm, obtained the Approval for Drug Replenishment Application (Approval No.: 2018B03173) approved and issued by the State Drug Administration, thus becoming the first batch of montmorillonite products passing the generic drug consistency evaluation. The approval of the project marked a major breakthrough in the consistency evaluation of Tibet AIM Pharm's generic drugs.
On March 5, 2016, the General Office of the State Council officially issued the Opinions on Conducting the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (GBF [2016] No. 8), which clarified the scope and time limit of the consistency evaluation and required the consistency of quality and efficacy with original drug and clinically mutual replacement with original drug.
In active response to the policies of the General Office of the State Council and related departments, Tibet AIM Pharm established a consistency evaluation working group to mainly evaluate the quality and efficacy of multiple self-owned drugs, always follow the requirements of the national medical policy, take quick action only to improve product quality, ensure product efficacy, so that Chinese patients use drugs that are consistent with the quality and efficacy of developed countries with better cost-effectiveness.
For over 2 years, Tibet AIM Pharm conducted a comprehensive study on the formulation process, quality and stability, key quality attributes, etc. of montmorillonite powder, using modern detection technology to measure API foundation identification, BET and total pore volume, adsorption force, sedimentation volume, heavy metals, adsorption efficiency of in vitro bacteria, and developed a unique multi-phase quantitative analysis method to control product content and impurities, developed more stringent product release standard based on current standard to ensure the safety and effectiveness of the product.
Bear the original intention in mind and forge ahead. Through the professional and rigorous review of drug review center, strict on-site verification of review verification center, rigor but fair notarized product review of drug test institute, it finally obtained the final review of the State Drug Administration. In June 2018, Tibet AIM Pharm “Montmorillonite Powder” was approved for the consistency of quality and efficacy.
Taking independent innovation as the source of enterprise development, Tibet AIM Pharm continuously improves the “imitation and innovation” drug research and development innovation system. Taking “continuously providing high-quality and high-quality medicines with great clinical value” as our corporate mission, we will take “helping patients overcome diseases and always safeguarding people's health” as our corporate vision and strive to become a leading generic drug pharmaceutical company nationwide. Tibet AIM Pharm will continue to promote the consistency evaluation of multiple products with the aim of “high quality” and “good efficacy”.
Tibet Aim Pharmaceuticals Techonology Ltd.
