Milrinone

Heart failure is a severe cardiovascular disease with high morbidity and mortality worldwide, and positive inotropic drugs are one of the core medications for acute intervention in advanced decompensated heart failure. Milrinone is a non-digitalis positive inotropic drug belonging to the phosphodiesterase Ⅲ (PDE-Ⅲ) inhibitor category. It selectively inhibits the activity of PDE-Ⅲ in myocardium and vascular smooth muscle, increases the concentration of cyclic adenosine monophosphate, and exerts the dual effects of enhancing myocardial contractility and dilating peripheral vessels at the same time. It can reduce the preload and afterload of the heart without significantly increasing myocardial oxygen consumption. Clinically, it is mainly used for acute and chronic refractory congestive heart failure caused by various reasons that are unresponsive or have poor response to digitalis, diuretics and vasodilators, and is especially suitable for short-term hemodynamic support of heart failure patients with pulmonary hypertension.

The market size of milrinone preparations in China has maintained a steady growth trend in recent years. In 2023, the market size was approximately RMB 1.87 billion, with a compound annual growth rate maintained at around 7%. In terms of the competitive landscape, the current domestic market is dominated by generic drug supplies. More than 20 enterprises have obtained marketing approval for milrinone injection, and this variety has been included in multiple batches of the national centralized procurement catalog. The selected price in centralized procurement has dropped by more than 90% compared with the highest price of the original research drug, and the market share in public medical institutions is gradually concentrating on leading generic drug enterprises. Cost control and supply stability of upstream API have become the core factors for generic drug enterprises to maintain market competitiveness.

The original research enterprise of milrinone is Sanofi, with the original brand name Primacor, and its core compound patent expired globally in the 1990s. The main dosage forms approved for the original research product are injections with specifications of 10ml:10mg and 20ml:20mg, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, nearly 10 enterprises have obtained CDE registration numbers for milrinone API with the status of "A", which can be legally supplied to preparation manufacturers. Multiple domestic generic milrinone injections have passed the consistency evaluation. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of milrinone impurity reference standards, covering the reference material requirements of the whole path including synthetic process impurities and degradation impurities. Most of the products have sufficient in-stock inventory. In-stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for API and preparation enterprises in links such as quality research, stability study and registration submission.