Labeler · US market

Leadiant Biosciences, Inc.

Leadiant Biosciences, Inc. is a US drug labeler with US FDA registrations covering 5 drug concepts (5 currently active) across 9 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes54482

Active drugs5

Registrations7 active / 7

Packages9

Sole supplier of1 drugs

Portfolio5 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Levocarnitine solution	rx	2	4	SUPPLYING
Cysteamine Hydrochloride solution	rx	2	2	SUPPLYING
Procarbazine Hydrochloride capsule	rx	1	1	SUPPLYING
Levocarnitine injection, solution	rx	1	1	SUPPLYING
Levocarnitine tablet	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Procarbazine Hydrochloriderx

At a glance

TypeLabeler
Labeler codes54482
Filing names1
Drugs (active)5
Drugs (all time)5
US registrations7
Packages9

Recent events

Shortages, recalls, and registration changes across all filing names.

Aug 8, 2025
RESOLVEDShortage resolved: Amphotericin B Injection (Leadiant Biosciences, Inc.)
Aug 8, 2025
SHORTAGEDrug shortage: Amphotericin B Injection (Leadiant Biosciences, Inc.)
Feb 3, 2023
RECALLRecall (Class II): Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indiana…
Sep 24, 2020
RECALLRecall (Class III): Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured…
Apr 9, 2018
RECALLRecall (Class III): Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amit…
Feb 14, 2018
RECALLRecall (Class III): Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Ami…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.