Alverine

Gastrointestinal smooth muscle spasm is a common clinical symptom in the department of gastroenterology. It often recurs accompanied by diseases such as irritable bowel syndrome, intestinal spasm and biliary spasm, which seriously affects patients' daily work and quality of life. Alverine is a selective smooth muscle relaxant. It can specifically act on the smooth muscles of the gastrointestinal tract and genitourinary system by affecting the permeability of ion channels and inhibiting the contraction reflex of smooth muscles. It exerts an antispasmodic effect without producing atropine-like adverse reactions, and is approved for indications including relieving irritable bowel syndrome, intestinal spasm, abdominal pain, pain caused by diverticulitis, as well as biliary spasm, dysmenorrhea, uterine spasm, etc. Adults and adolescents over 12 years old can use it safely.

At present, the global alverine market size is stable at around USD 120 million, with an annual compound growth rate maintained at 2.1%. Market demand is mainly concentrated in the long-term medication scenario of antispasmodic and analgesic in the department of gastroenterology. For the domestic market, as the prevalence of irritable bowel syndrome has risen to 6.5%, the clinical demand for antispasmodic drugs with low adverse reactions continues to rise. At present, domestic generic preparations have accounted for nearly 75% of the market share, and the supply of APIs has gradually realized domestic substitution. It has not been included in the national centralized volume procurement scope, and the market competition pattern is relatively stable.

The original research enterprise of alverine is Laboratoires UPSA of France, and the original research trade name is Spasmonal®. Its core compound patent expired globally in 2000. The main dosage form of the original research product is hard capsule, with two specifications of 60mg and 120mg. It has been included in the reference preparation catalogs of the EU and FDA, and the domestic reference preparation catalog also includes this original research variety. Up to now, 3 domestic enterprises have obtained A status for their alverine APIs through CDE registration, and another 5 enterprises have obtained marketing approval for alverine capsules. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of alverine impurity reference standards, which fully cover impurities from the synthesis process, degradation impurities and all quality control impurities specified in pharmacopoeias. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises for quality research, stability investigation and registration declaration.