Overview
Amgen Inc. is a leading biotechnology company that develops innovative therapies for serious illnesses. It focuses on areas of high unmet medical need and leverages its expertise in molecular biology and genetics to discover, develop, and deliver innovative human therapeutics.
Therapeutic areas
API / Drug Master Files
Amgen Inc. holds 6 active (7 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.
- AMG 157 (TEZEPELUMAB) PHASE 3 CMC AMENDMENT (DRUG SUBSTANCE AND DRUG PRODUCT)Active2017-08-21
- INTRAVENOUS SOLUTION STABILIZER (IVSS)Active2017-04-20
- AMG 282 DRUG SUBSTANCEActive2016-02-22
- AMG 191 CELL LINE DEVELOPMENTActive2015-11-06
- AMG 191 DRUG PRODUCTActive2015-11-06
- AMG 191 DRUG SUBSTANCEActive2015-11-06
- HUMAN MONOCLONAL ANTIBODY (MDX-015)(SP2/0,- AG14 CELLS, MEDAREX) TO IL15Inactive2001-04-02
FDA compliance signals
17 FDA enforcement records linked to this company.
- recall — Class II2025-03-26
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
- recall — Class II2025-03-26
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
- 4832025-03-13
No written record of investigation
- 4832025-03-13
Procedures for sterile drug products
- 4832025-03-13
Acceptance of in-process materials
- 4832025-03-13
Systems in place to comply with verification requirements
- recall — Class II2022-05-18
Defective container: loose crimp defect, potential loss of container integrity.
- 4832019-12-13
Cleaning SOP/inspection
- recall — Class II2017-09-27
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
- recall — Class II2017-08-23
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
- recall — Class II2016-12-28
Lack of Assurance of Sterility: Potential cracks in glass vials
- warning_letter2014-01-27
FDA Warning Letter (drug product)
- recall — Class II2013-11-13
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
- 4832012-12-12
Failure by applicant to report ADE
- 4832012-12-12
Failure to report post-marketing study ADEs
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