Laboratorios Farmacéuticos Rovi (ROVI) has announced that the US Food and Drug Administration (FDA) has approved its contract manufacturing injectables plant in Madrid for filling syringes that are prefilled with water for injection using the terminal sterilisation process.
Syringes prefilled with water for injection by ROVI at its contract manufacturing plant will be able to be commercialised in the US in the coming months.
CEO of ROVI Juan López-Belmonte Encina said: "FDA approval represents a significant milestone in our manufacturing capacity and an excellent opportunity to penetrate the US market and maximise the plant’s potential. In addition, it reflects our continuous interest in serving the globalised pharmaceutical market."
With more than fifteen years of experience, ROVI specialises in filling and packaging parenteral
solutions in prefilled syringes and vials. ROVI is currently one of the world’s leading
manufacturers of prefilled syringes, with annual production capacity of 180 million prefilled
syringes.