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Medicilon assists pharmaceutical companies to successfully pass the consistency evaluation

2019-10-30
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Recently, Medicilon’s CMC preparations have developed another success. Amlodipine besylate tablets, a cardiovascular drug 289 base drug project developed for customers for lowering blood pressure, has been obtained by the National Medical Products Administration (NMPA). This is one of the consistency evaluation drugs approved by Medicilon and its customers. The project lasted for nearly 3 years, from registration acceptance to approval nearly 11 months, for the complete formulation development services.

It is reported that the pharmaceutical research content of the project includes: reference preparation research, pre-formulation research, prescription screening and process optimization, laboratory scale-up, preliminary stability, quality research, pilot scale-up and process verification (provide technical support, transfer analysis methods and production process transfer), stability research and filing data sorting, etc.
In order to smoothly develop the formulation of amlodipine besylate tablets, Medicilon strictly complies with the requirements of the national policy, combined with reverse engineering and the latest technological progress, to make every effort to complete the project. All the research and development content and development process of the project meet the latest regulations of the drug regulatory authority, ICH and related guidelines, including potential genotoxicity research in accordance with ICH M7. Through in-depth research on the prescription process, the ideal prescription composition and preparation process have been obtained. At the same time, the pre-BE and BE research have been passed at one time, which saves the development time and development cost for the customer, and is highly recognized by the customer.

Shanghai Medicilon has rich experience in formulation development services and has carried out generic drug consistency evaluation studies for many customers. At present, many varieties have completed the CDE approval and successfully passed the development on-site verification, and will continue to obtain consistency evaluations. Approval. At the same time, Medicilon also has many successful cases in the development of innovative drug preparations.

After years of development, Medicilon has accumulated rich experience and successful cases in the development of CMC formulations. Welcome new and old customers to consult and cooperate!

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