RESONANCE LABORATORIES PVT LTD

Overview

RESONANCE LABORATORIES PVT LTD is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering ATROPINE SULFATE; CLIDINIUM BROMIDE USP; GLYCOPYRROLATE; OXYBUTYNIN CHLORIDE (OBTN).

API / Drug Master Files

RESONANCE LABORATORIES PVT LTD holds 4 active (5 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.

• ATROPINE SULFATEActive2015-09-24
• GLYCOPYRROLATEActive2012-09-17
• CLIDINIUM BROMIDE USPActive2011-03-05
• OXYBUTYNIN CHLORIDE (OBTN)Active2010-04-14
• BUPRENORPHINE HYDROCHLORIDE (BPNH)Inactive2010-04-14

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to RESONANCE LABORATORIES PVT LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.