上海葆隆生物科技有限公司
Shanghai Baolong Biotech Co.,ltd

ANDA formulation strategy

  • Select of RLD, overall profile of RLD

  • Development of analytical methods

  • Screening of critical excipients

  • Formulation development by screening CQAs

  • Process optimization based QbD

  • Container closure system select and research

  • Scale up and technical transfer

  • Method qualification

  • Specification research

  • Stability research

NDA formulation strategy

  • Pre-formulation research

  • Dosage form selection based on API chemical-physical properties, clinical need, excipients and equipments.

  • Chemical and physical research of API , including appearance, hardness, flowability, and stability.

  • Salt formation research

  • Polymorphism research

  • Powder properties research (bulk density, tapped density, particle size distribution and flowability)

  • Compatibility research of API and excipients

  • Formulation research

  • Preparation of clinical samples