KEY ADVANTAGES
Functional equivalence - Meets EP 10.3/USP <601> standards for:
- Fine Particle Fraction (FPF)
- Lung Deposition Consistency
Bioequivalence confirmed - PK study demonstrates:
-AUC0-t and Cmax ratios compliant with FDA 21 CFR 320 & EMA CHMP/EWP/240/95 criteria
Customization options:
- Appearance personalization
- Integrated sensor:
APP notifications with adherence tracking
Real-time Flow Profiling
Regulatory support：
- Validation/clinical/commercial batches
- Complete DHF & DMF documentation
- ICH stability data (accelerated/long-term)
- CE Marked & China NMPA Class I (Reg. No.: SSXB20232113)
Compatible Formulations
|
Compatible Medications |
Key Clinical Benefits |
|
Tiotropium |
Precisely targeted lung delivery |
|
Advanced DPI Solutions |
Custom-engineered formulations for optimal delivery |
