Overview

Durect Corporation is a biopharmaceutical company engaged in the research and development of pharmaceutical products based on its proprietary drug delivery technology. The company's product pipeline is focused on the treatment of chronic pain and other medical needs.

Therapeutic areas

Chronic PainAnesthesiaLiver Diseases

API / Drug Master Files

Durect Corporation holds 4 active (4 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.

  • DUR-928-AActive2022-03-14
  • PLACEBO FOR DUR-928 TOPICAL SOLUTIONActive2018-07-17
  • DUR-928 TOPICAL SOLUTIONActive2018-07-16
  • DUR-928Active2016-12-22

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Durect Corporation in our records. PharmaTek screens the full directory against live FDA enforcement data.

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