OMSAV PHARMA RESEARCH PRIVATE LTD

Overview

OMSAV PHARMA RESEARCH PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering FLECAINIDE ACETATE USP; NITROFURANTOIN MONOHYDRATE USP; NITROFURANTOIN MACROCRYSTALS USP.

API / Drug Master Files

OMSAV PHARMA RESEARCH PRIVATE LTD holds 3 active (3 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.

• FLECAINIDE ACETATE USPActive2022-06-20
• NITROFURANTOIN MACROCRYSTALS USPActive2021-11-03
• NITROFURANTOIN MONOHYDRATE USPActive2021-10-26

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to OMSAV PHARMA RESEARCH PRIVATE LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.