ACTAVIS GROUP PTC EHF

Overview

ACTAVIS GROUP PTC EHF is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE); CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE); IMIQUIMOD USP [NON-STERILE DRUG SUBSTANCE]; RIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE); VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)].

API / Drug Master Files

ACTAVIS GROUP PTC EHF holds 5 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.

• CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE)Active2010-06-23
• VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]Active2010-05-06
• RIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE)Active2009-11-10
• ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE)Active2009-07-24
• IMIQUIMOD USP [NON-STERILE DRUG SUBSTANCE]Active2008-05-08

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ACTAVIS GROUP PTC EHF in our records. PharmaTek screens the full directory against live FDA enforcement data.