ROVI PHARMA INDUSTRIAL SERVICES SA

Overview

ROVI PHARMA INDUSTRIAL SERVICES SA is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering STERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGE; STERILE WATER FOR INJECTION 2.2ML PREFILLED SYRINGE; STERILE WATER FOR INJECTION USP 0.5 ML; STERILE WATER FOR INJECTION, 0.5-1.0 ML PREFILLED SYRINGE; STERILE WATER FOR INJECTION, 5-10 ML PREFILLED SYRINGE; STERILE WATER FOR INJECTION, USP, 5.0 ML.

Core services & business areas

API / Drug Master Files

ROVI PHARMA INDUSTRIAL SERVICES SA holds 6 active (8 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• STERILE WATER FOR INJECTION, 0.5-1.0 ML PREFILLED SYRINGEActive2023-01-10
• STERILE WATER FOR INJECTION, 5-10 ML PREFILLED SYRINGEActive2016-07-25
• STERILE WATER FOR INJECTION 2.2ML PREFILLED SYRINGEActive2016-03-18
• STERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGEActive2012-12-28
• STERILE WATER FOR INJECTION, USP, 5.0 MLActive2011-08-17
• STERILE WATER FOR INJECTION USP 0.5 MLActive2010-07-22
• STERILE WATER FOR INJECTION, 1 ML PREFILLED SYRINGEInactive2013-10-28
• STERILE WATER FOR INJECTION USP 2.0 MLInactive2010-07-22

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ROVI PHARMA INDUSTRIAL SERVICES SA in our records. PharmaTek screens the full directory against live FDA enforcement data.