Gilead Sciences, Inc.
Overview
Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops, and commercializes therapeutics in areas of unmet medical need. With a portfolio of drugs in various stages of development, the company is known for its work in the fields of HIV, liver diseases, and cancer.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Gilead Sciences, Inc. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
Gilead Sciences, Inc. holds 3 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.
- COBICISTAT ON SILICON DIOXIDEActive2011-10-24
- ELVITEGRAVIRActive2011-10-21
- AMBISOME, LIPOSOMAL AMPHOTERICIN BActive1992-03-06
- LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211)Inactive2002-11-06
- LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L)Inactive2002-06-28
- FK506LC AND PLACEBOInactive2001-10-12
- PMPA GELInactive1997-10-07
FDA compliance signals
30 FDA enforcement records linked to this company.
- 4832026-02-18
Sterility/pyrogens - test methods written, followed
- 4832026-02-18
Procedures for sterile drug products
- 4832026-02-18
Procedures not in writing, fully followed
- 4832026-02-18
Reserve samples identified, representative, stored
- 4832026-02-18
Following/documenting laboratory controls
- 4832026-02-18
Scientifically sound laboratory controls
- 4832026-02-18
Annual visual exams of drug products
- recall — Class I2024-10-09
Presence of Particulate Matter: Presence of glass particle.
- 4832024-01-22
Late submission of 15-day report
- recall — Class I2022-01-05
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
- 4832021-12-17
Buildings not maintained in good state of repair
- 4832021-12-17
Training , Education , Experience overall
- 4832021-12-17
Procedures not in writing, fully followed
- 4832021-12-17
Validation lacking for sterile drug products
- 4832018-07-17
Late submission of 15-day report
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