L-carnitine

Orphan DrugFDA Approved, EMA Approved

Description

L-carnitine is an amino acid derivative essential for fatty acid metabolism and energy production in mitochondria. It is used in metabolic disorders affecting mitochondrial function and has orphan designation for primary carnitine deficiency. The drug facilitates transport of long-chain fatty acids into mitochondria for beta-oxidation.

Indications & Therapeutic Use

primary carnitine deficiency, metabolic disorders with mitochondrial dysfunction, fatty acid oxidation disorders

Global Availability (9 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
L-carnitine
Generic NameL-carnitine
Brands1 brand available
Active Ingredientlevocarnitine
Drug Classprimary carnitine deficiency
ManufacturerLeadiant Biosciences
Dosage FormsOral tablets 330mg; oral solution 100mg/mL; IV injection 200mg/mL
Medical CodeA16AA01
Orphan StatusYes — Orphan Drug
Cold ChainNot Required
Lead Time5 days
Reg. StatusFDA Approved, EMA Approved
Clinical TrialNCT00006250
Countries9 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations10 Validated Nodes