Leadiant Biosciences, Inc.
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.
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