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Prescription Process Development
Based on the customer’s requirements and physicochemical properties of the API and excipients, the most suitable dosage form will be selected and the formulation and process will be established as well as corresponding process control parameters.
Formulation and Process Development Capability:
◆Selection and analysis of reference products | ◆Screening of API, excipients and packaging materials |
◆ Reverse engineering study for generic products | ◆QbD-based optimization of formulation and process parameters |
◆Compatibility and stability study | ◆Process scale-up and technology transfer |
The Development Capability of Innovative Drug Products:
Sterile Formulation Technology | Non-sterile Formulation Technology | Featured Formulation Technology |
Injectable microspheres technology | Solid dispersion technology | Oral film technology |
Long-acting implant technology | Oral nanocrystal Technology | Transdermal technology |
Injectable nanocrystalline/nanoparticle technology | Gastral-retention technology | Dry suspension technology |
Injectable gel technology | Osmotic pump technology | Oral disintegration tablet technology |
injectable liposome technology | Matrix sustained release technology | Enteric-coating technology |
Injectable emulsion/nano-emulsion technology | Pellet release technology | Soft-gel technology |
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