Vetter works directly with your team to provide you with a seamless WFI manufacturing service. This includes validation and stability data for your WFI applications.
Complete CTD Section 3.2.P compiled according to the applicable EMA regulations; Type II Drug Master File # 11614 'Sterile Water for Injection as manufactured in Langenargen, Germany' available for USA.
Stability data in compliance with USP, Ph.Eur., PH.J. and ICH guidelines.
Additional features include:
- Extended shelf life (4-year target)
- Premium quality packaging materials
- Tamper evidence function
- Stable pH value
- Reduced leachables
- Coverage of entire fill range from 0.5 ml - 3 ml
- Multiple dossier usage capabilities
With Vetter, your WFI product rollout will benefit from a faster time-to-market, combined with a superior level of quality and service.
Flyer "Pre-filled Water for Injection Syringes"
