Levocarnitine

Patients with chronic renal failure undergoing long-term dialysis often suffer from complications such as muscle spasm and arrhythmia due to insufficient carnitine synthesis and carnitine loss during dialysis, and such clinical demands have promoted the application and popularization of levocarnitine. Levocarnitine is a metabolism-promoting drug, which can promote the oxidative decomposition of fatty acids in mitochondria to supply energy, and reduce the accumulation of toxic metabolites in the myocardium and skeletal muscle. In clinical practice, in addition to being used for dialysis-induced secondary levocarnitine deficiency, it can also improve the myocardial energy metabolism of patients with coronary heart disease and cardiomyopathy, and assist in improving the sperm motility of patients with male oligoasthenospermia. The applicable population covers patients in multiple departments such as nephrology department, cardiology department and reproductive department.

The global levocarnitine market size was approximately USD 780 million in 2023, and is expected to maintain a compound annual growth rate of 4.2% from 2024 to 2030. In the domestic market, generic drugs account for more than 90%, there are more than 130 existing approvals for levocarnitine preparations, the supply of APIs presents a characteristic of head concentration, and the production capacity of domestic enterprises accounts for more than 75% of the total global supply. In the eighth batch of nationally organized centralized drug procurement, the average price cut of winning bids for levocarnitine injection reached 73%, which further promoted the increase of clinical penetration rate, and the demand for upstream APIs has also sunk into the primary medical market.

The original research enterprise of levocarnitine is Sigma-Tau, with the original trade name "Carnitor". Its core compound patent expired globally in 1999, and there is no valid core patent restriction at present. The main dosage forms approved for the original product include injection (1g/5ml, 2g/10ml) and oral solution (1g/10ml), among which the injection has been included in the *Reference Listed Drug Catalogue of Chemical Drugs* issued by NMPA, and is also listed as an FDA reference listed drug. Up to now, there are 28 levocarnitine registration numbers in the domestic CDE API registration platform, 22 of which are in the status of "A" (approved for use in marketed preparations). The domestically approved and marketed levocarnitine preparations cover three major dosage forms: injection, oral solution and tablet. (Data as of October 2024, please refer to the official CDE website for the latest data)

CATO provides a full set of impurity reference standards for levocarnitine. The products strictly meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most impurities are available from stock, and stock orders placed before 16:00 can be shipped on the same day, which can fully meet the various needs of pharmaceutical enterprises in generic drug consistency evaluation, quality research and routine release testing.