Overview

Leadiant Biosciences, Inc. is a pharmaceutical company focused on developing and delivering therapies that address the unmet needs of patients with rare diseases. It operates as a subsidiary of Leadiant Biosciences S.p.A., which is based in Italy.

Therapeutic areas

FDA compliance signals

5 FDA enforcement records linked to this company.

  • recall — Class II2023-02-22

    Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

  • 4832021-07-08

    Interval

  • recall — Class III2020-10-21

    Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

  • recall — Class III2018-04-25

    Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.

  • recall — Class III2018-03-07

    Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.

Ready to Accelerate Your
Discovery Workflow?

Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.