Overview

Sarepta Therapeutics, Inc. is a medical research and drug development company focused on developing precision genetic medicines to treat rare neuromuscular diseases. With a primary emphasis on Duchenne muscular dystrophy, the company utilizes innovative RNA-based platforms to address unmet medical needs.

Therapeutic areas

Neuromuscular diseasesGenetic disorders

API / Drug Master Files

Sarepta Therapeutics, Inc. holds 0 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.

  • SRP-2001 DRUG SUBSTANCEInactive2023-02-28

FDA compliance signals

1 FDA enforcement record linked to this company.

  • 4832018-04-12

    Periodic safety report missing ICSR

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