AstraZeneca AB

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.

Therapeutic areas

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