CSL Behring LLC

King of Prussia, Pennsylvania, United States

Overview

CSL Behring is a global biotechnology company focused on the development of innovative biotherapies. As a subsidiary of CSL Limited, it specializes in treatments for rare and serious diseases, leveraging its expertise in immunology and hematology.

Therapeutic areas

ImmunologyHematologyRespiratoryCardiovascularNeurology

API / Drug Master Files

CSL Behring LLC holds 1 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.

  • STERILE WATER FOR INJECTIONActive2006-03-17
  • ISCOMATRIX ADJUVANTInactive2009-10-29

FDA compliance signals

4 FDA enforcement records linked to this company.

  • 4832026-02-18

    Procedures to be written and followed

  • 4832026-02-18

    Changes to Procedures Not Reviewed, Approved

  • 4832026-02-18

    Procedures not in writing, fully followed

  • 4832026-02-18

    Cleaning / Sanitizing / Maintenance

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