API R&D Services

• Route design, selection and development
• Scale up process evaluation and optimization
• Impurity synthesis, identification and quantification
• API quality research , analytical method development &validation, analytical method transfer , stability study
• Regulatory module (CTD, DMF) writing up and submission

 Formulation R&D Services

including :

• New Drug Application ( NDA)
• 505b(2)
• ANDA

Various dosage forms

• Oral solution formulation (solution, suspension)
• Oral solid dose formulation (tablets, capsules, granules, dry suspension, powder)
• Parenteral formulation (injection, lyophilized powder)
• Topical formulation (cream, emulsion, gel, patch)

ANDA formulation R&D strategy:

• RLD selection and overall profile setting up
• Process development by screening of critical excipients, and CQAs.
• Drug product packaging selection
• Scale up and technical transfer
• Method qualification
• Specification research
• Stability studies

 NDA formulation R&D strategy:

• Pre-formulation research
• Dosage form selection based on API chemical-physical properties, clinical need, excipients and equipments
• Chemical and physical studies of API, including appearance, hardness, flowability, and stability.
• Salt formation& Polymorphism studies
• Powder properties studies (bulk density, tapped density, particle size distribution and flowability)
• Compatibility research of API and excipients
• Formulation research
• Preparation of clinical samples