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Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients

Medicilon currently features a cGMP-based API production line based on IND requirements. From preclinical laboratory-scale testing and process development to commercialized production, we meet the needs of our clients throughout the comprehensive supply chain, including R&D, purchase and production. From the mg- and g-level to kg level, our processes allow flexible adjustments to fit in client innovative process R&D and scale production.

From QBD-oriented process design to process R&D in laboratories, commercialized production to data-based filings, our analysis and quality inspection teams promise professional services and comprehensive analytical research, including method development and verification, process verification, impurity identification and separation, API and intermediates research, and API stability tests.

With years of experience and the construction of laboratories, the Medicilon Process Department can not only perform R&D, testing and stability studies of generic drugs for customers, but also R&D, production, testing and stability studies of innovative drugs in clinical phase I and phase II, gradually developing from process R&D to industrial commercial production and transforming from CRO to CDMO.