ACEBRIGHT INDIA PHARMA PRIVATE LTD

Overview

ACEBRIGHT INDIA PHARMA PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering DABIGATRAN ETEXILATE MESYLATE [DRUG SUBSTANCE (NON-STERILE)]; IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)]; IMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)]; LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)].

API / Drug Master Files

ACEBRIGHT INDIA PHARMA PRIVATE LTD holds 4 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.

• DABIGATRAN ETEXILATE MESYLATE [DRUG SUBSTANCE (NON-STERILE)]Active2020-10-31
• LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)]Active2014-04-28
• IMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)]Active2012-09-11
• IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)]Active2012-08-17

FDA compliance signals

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