ASENCE PHARMA PRIVATE LTD

Overview

ASENCE PHARMA PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering AMPHOTERICIN B USP [INTENDED FOR USE IN PREPARING PARENTERAL DOSAGE FORMS]; AMPHOTERICIN B USP [ORAL GRADE]; GLYCOPYRROLATE USP.

API / Drug Master Files

ASENCE PHARMA PRIVATE LTD holds 3 active (4 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.

• AMPHOTERICIN B USP [INTENDED FOR USE IN PREPARING PARENTERAL DOSAGE FORMS]Active2012-09-05
• AMPHOTERICIN B USP [ORAL GRADE]Active2012-06-28
• GLYCOPYRROLATE USPActive2005-12-10
• AMPHOTERICIN BInactive1998-11-05

FDA compliance signals

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