Gilead Sciences, Inc.

Foster City, California, United States gilead.com

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.

Therapeutic areas

HIV/AIDSLiver diseasesCancerInflammatory diseasesRespiratory diseases

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

    Scientifically sound laboratory controls

  • 4832026-02-18

    Sterility/pyrogens - test methods written, followed

  • 4832026-02-18

    Procedures not in writing, fully followed

  • 4832026-02-18

    Procedures for sterile drug products

  • 4832026-02-18

    Following/documenting laboratory controls

  • 4832026-02-18

    Annual visual exams of drug products

  • 4832026-02-18

    Reserve samples identified, representative, stored

  • 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

    Procedures not in writing, fully followed

  • 4832021-12-17

    Training , Education , Experience overall

  • 4832021-12-17

    Validation lacking for sterile drug products

  • 4832021-12-17

    Buildings not maintained in good state of repair

  • 4832018-07-17

    Late submission of 15-day report

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