Pipecuronium bromide

As a representative variety of long-acting non-depolarizing muscle relaxants, pipecuronium bromide competitively binds to the N2 cholinergic receptors on the motor end-plate of skeletal muscle, blocks the depolarization effect of acetylcholine, and thus achieves muscle relaxation effect. It has minimal impact on the cardiovascular system and no risk of histamine release, making it particularly suitable for surgical anesthesia in patients with coronary artery disease, cardiac insufficiency and elderly patients. It is the preferred option for muscle relaxation management in cardiac surgery and long-time complex surgeries, and can effectively reduce the incidence of adverse events such as body movement and patient-ventilator asynchrony during surgery.

The global market size of pipecuronium bromide is approximately USD 120 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the increase in the number of surgeries for the elderly and the popularization of complex surgical procedures. The domestic market is still dominated by generic drug supply at present. After this variety was included in the local centralized procurement scope in 2022, the terminal price dropped by 68%, and the market share of the selected enterprises increased rapidly. Up to now, 3 domestic enterprises have obtained marketing approval for their preparations of this product, and the overall supply of APIs presents a stable competitive landscape.

The original research enterprise of pipecuronium bromide is Gedeon Richter Plc. of Hungary, and the original brand name is "Arduan". The core compound patent of this product expired in 2006 in major markets such as the European Union and the United States, and the compound patent in China also expired in 2006. The main dosage form approved for the original research product is powder for injection, with specifications including 4mg and 10mg. The 4mg specification has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed in the FDA Reference Preparations Catalogue. At present, 6 domestic enterprises have obtained A status for their pipecuronium bromide APIs through CDE registration, which can be used for associated preparation declaration, and 5 domestic pipecuronium bromide injections have been approved for marketing. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for pipecuronium bromide, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in API quality research, impurity control and preparation declaration.