Overview

AstraZeneca AB is a global, science-led biopharmaceutical company that develops, manufactures, and markets prescription medicines for a variety of disease areas. It is particularly strong in oncology, cardiovascular and renal diseases, respiratory, and immunology. As one of the leaders in biopharmaceutical innovation, AstraZeneca operates in over 100 countries.

Core services & business areas

Pharmaceutical ManufacturingQuality ControlSupply Chain ManagementRegulatory ComplianceResearch & DevelopmentRegulatory AffairsMarketing and Sales

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances AstraZeneca AB 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

AstraZeneca AB holds 2 active (2 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.

  • OMEPRAZOLE MAGNESIUM DRUG SUBSTANCEActive1997-10-31
  • PRILOSEC MUPS TABLETS (OMEPRAZOLE MAGNESIUM)Active1997-10-09

FDA compliance signals

2 FDA enforcement records linked to this company.

  • 4832017-02-07

    OTC products requiring tamper-evident packaging

  • 4832017-02-07

    Retest of approved components/containers/closures

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