MedImmune, LLC

Overview

MedImmune, LLC is a biotechnology company focused on the discovery, development, and commercialization of monoclonal antibody therapies. It operates as the global biologics research and development arm of AstraZeneca. The company is known for its innovative pipeline in areas such as oncology, respiratory, and immunology.

Therapeutic areas

API / Drug Master Files

MedImmune, LLC holds 0 active (3 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.

• HUMANIZED MONOCLONAL ANTIBODY (MEDI-522) TO THE VITRONECTIN (ALPHA-5 BETA-3) RECEPTORInactive2001-03-13
• SIPLIZUMAB [HUMANIZED MONOCLONAL ANTIBODY (MEDI-507) (NSO CELLS, MEDIMMUNE) TO CD2]Inactive1997-03-27
• HUMANIZED MONOCLONAL ANTIBODY (HULM609) TO HUMAN VITRONECTIN RECEPTORInactive1996-12-23

FDA compliance signals

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