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.
We provide API process development, optimization, manufacturing, and filing services, based on IND requests in preclinical and clinical phases.
Medicilon has been actively developing new technologies platforms, integrating emerging methods of green chemistry into its services, using photoredox chemistry, electrochemistry, catalyst screening and continuous reactions, to provide our customers with high-quality economic solutions.
Medicilon's pharmaceutical solid-state research service platform is dedicated to crystal form research services in the development of new drugs and generic drugs. It can provide salt form and polymorph screening, single crystal culture and structure analysis, crystallization process development, chiral separation and other services to assist global pharmaceutical research and development.
The solid screening platform of Medicilon process department strictly complies with the regulations and regulatory requirements of the NMPA, FDA and other regulatory authorities. It controls the solid morphology of drug molecules in API and preparations and can formulate the optimal screening strategy according to the material characteristics, including but not limited to crystallization method, solvent selection and ion selection.
marketing@medicilon.com
