Our injectable plants offer pre-filled water for injection (WFI) syringes in different sizes and volumes, produced according to European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) requirements.
Module 3 Common Technical Document (CTD) dossiers and Drug Master Files (DMF) are available to our WFI clients at no additional cost in order to facilitate the registration process.
Shelf life: 3 -4 years
Syringe types and volumes:
1 ml filled to 0.5 ml
1.25 ml filled at 1 ml bracketing strategy (all sizes from 0.5 to 1 ml)
3 ml filled to 2 ml
10 ml filled from 5 to 10 ml bracketing strategy (all sizes from 5 to 10 ml)
20 ml filled to 15 and 20 ml
Rovi WFI will provide following advantages:
Reliable filling process
Easy, ready-to-use products
Volumes and sizes fitting with your needs
Bracketing approach: Fast time to market (FDA- and EMA-approved)