Reliable Filling Process. Easy, Ready-To-Use Products
Source: ROIS
Our injectable plants offer pre-filled water for injection (WFI) syringes in different sizes and volumes, produced according to European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) requirements.
Syringe types and volumes:
- 1.25 ml filled from 0.5 to 1 ml. Bracketing strategy (all sizes from 0.5 to 1 ml)
- 3 ml filled to 2.18 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
- Bracketing approach: Fast time to market (FDA- and EMA-approved)
Our injectable plants offer pre-filled water for injection (WFI) syringes in different sizes and volumes, produced according to European Pharmacopoeia (Ph. Eur.) and the 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