High-quality research helps consistency evaluation, and the cooperative enterprise MAH will catch up with the new round of collection after being newly approved
Release time:
2022-07-19
The dust of the seven batches of centralized procurement has not yet been settled. Centralized procurement at the national and local levels has become normalized, triggering the reshaping of the industry and earth-shaking changes in rules. If a company is not fully prepared, does not change, accept and learn, and fails to improve, update, expand product pipelines, and reserve superior products, it will be a matter of time before it falls behind.
The dust of the seven batches of centralized procurement has not yet been settled. Centralized procurement at the national and local levels has become normalized, triggering the reshaping of the industry and earth-shaking changes in rules. If a company is not fully prepared, does not change, accept and learn, and fails to improve, update, expand product pipelines, and reserve superior products, it will be a matter of time before it falls behind.
Looking back at the seventh batch of collective purchases, some people are beaming with joy, some are licking blood from their knives, and some are healing their wounds alone ... In this baptism, many new faces have appeared on the scene with products that have received bad reviews, taking away market share. MAH licensees with no industrial foundation or R&D foundation have successfully counterattacked through resource integration, and centralized procurement has become a means and way for them to quickly enter the market. For example, a MAH company entrusted Jiqun Pharmaceutical to develop generic lidocaine injection drugs in plastic bottles instead of glass bottles, integrated processing resources, and quickly obtained the tickets for this round of bulk purchasing after being approved to join this round of centralized purchasing. , successfully won the bid. It was quickly launched on the market only 5 days after being approved, successfully achieving overtaking in corners. This may also be a kind of subversion, only fast will not break it!
Jiqun Pharmaceutical has established special research project teams for various varieties. The project leaders and project managers have nearly 10 years of R&D experience. Based on the concept of quality by design, a comprehensive and systematic research plan has been designed to conduct reverse analysis of the reference preparation. , using the same type and dosage of excipients as the reference preparation, conducted in-depth laboratory research on the prescription and process parameters, and assisted in completing industrial process verification, cleaning verification and other work on the production line; in terms of quality control, the focus was on pH, related Key quality indicators such as substances, elemental impurities, and content will be compared with reference preparations through comprehensive quality comparison, compatibility inspection, low-temperature freeze-thawing, and stability studies. Research data to improve compliance! While improving quality, we fully consider the cost control demands of each client and strive to give customers more space .
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