Strong Research & Development Capability
More than 92% of R&D team have a master’s degree or above with a very good education background and formulation development theory. The team has a very good formulation and process development experience and they can develop the product to clinical stages or commercialization quickly via scientific experimental design.
● Dosage form
Conventional tablet, cosmetic coated tablet, sustained release tablet, enteric coated tablet, capsule, granule, pellet.
● Technical platform
Nano-milling; bi-layer or multi-layer tablet; sustained release or controlled release coating; pellet drug loading or coating; solubilization for insoluble API; formulation platform for API with different BCS classification; DoE and process validation
● Project experience
Quality by Design (QbD) based formulation and process development of tablet, capsule and granule; evaluation and prediction of stability data; process design, scale-up, optimization and validation; process risk assessment and control.
Currently Asymchem has 3 independent cGMP oral solid dosage form facilities, which can quickly provide production services for different projects from IND to commercialization to meet the client’s needs at different stages.
● Dry granulation
● Wet granulation
● Spray drying
● Film coating and enteric coating
● Sachet package of granule
● Bottle and blister package of tablet and capsule
● Secondary packaging and labelling
● Can handle low OEL compound
A variety of state-of-art equipment and over 5,000m2 of validated cGMP facility have been well validated for pilot and commercial-scale production.
QbD based formulation and process development; solubilization of insoluble drug, such as solid dispersions via spray drying; registration batch and clinical batch manufacturing; process Design of Experiment (DoEs) and process validation; commercial product manufacturing.