EMD Serono, Inc.
Overview
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leading biopharmaceutical company that focuses on delivering innovative therapies to help patients worldwide. The company collaborates with Pfizer in specific therapeutic areas to develop and market treatments.
Therapeutic areas
API / Drug Master Files
EMD Serono, Inc. holds 1 active (1 total) FDA Type II Drug Master File — 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.
- MURINE MONOCLONAL ANTI-FSH ANTIBODY 9/14Active1995-05-08
FDA compliance signals
4 FDA enforcement records linked to this company.
- recall — Class II2020-07-15
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
- 4832016-06-17
Investigations of discrepancies, failures
- recall — Class III2015-09-23
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
- 4832012-08-21
Failure to investigate serious, unexpected events
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