ACTAVIS GROUP PTC EHF

Iceland

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)].

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances ACTAVIS GROUP PTC EHF is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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.

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