We have both formulation laboratory and pilot GMP-like workshop equipped with a number of international top equipments for oral solid dosage development. The formulation laboratory is mainly used for manual sample preparation and physical characterization for raw material, excipient and in-process intermediate. There are Alexanderwerk-WP120, Korsch-XL100, Leistritz-ZSE and Style'One-compaction simulator in pilot GMP-like workshop, most of the equipments are mobile that is very helpful for efficiency. Furthermore, the pilot GMP-like workshop is designed in accordance with requirements of FDA, EMA and NMPA, including separated personnel & material flow, pressure differential control, and changing rooms etc. The whole area is provided with a number of operating rooms on basis of common OSD process. Above all only one product is allowed to be manufactured in the same room at a time. The design concept not only maximizes employee safety but also improves control of cross-contamination.
Our analytical R&D lab provides comprehensive analytical services to supporting all stages of product and crystallization process development, for drug product manufacturing, including phase-appropriate analytical method development, validation, verification and transfer, drug product formulation process analytical support, ICH stability studies, forced degradation studies, physical-chemical property characterization, cleaning validation, material&product specifications, providing scientifically sound CMC data for regulatory submissions. Currently analytical facilities: UPLC/HPLC, HS-GC, Dissolution, Stability chambers and other general analytical instruments.