Denaverine

As a commonly used antispasmodic drug in clinical practice, drotaverine is a specific smooth muscle calcium antagonist. It blocks the signal transduction of smooth muscle contraction by inhibiting calcium ion influx, without affecting the regulatory function of the autonomic nervous system. It can not only rapidly relieve spastic pain in the gastrointestinal tract, biliary tract, urogenital tract and other parts, but also avoid the common adverse reactions of traditional anticholinergic antispasmodics such as dry mouth, palpitations and blurred vision. It is especially suitable for elderly patients, patients with glaucoma and people who need long-term control of spastic symptoms. At present, it has become one of the preferred options for symptomatic treatment of spastic diseases in departments of gastroenterology, urology, gynecology, etc.

At present, the global market size of drotaverine is approximately USD 180 million, with a compound annual growth rate maintained at around 4.2% in the past three years. The growth momentum mainly comes from the improvement of safety requirements for antispasmodic drugs in primary medical institutions and the increase in the consultation rate of elderly-related spastic diseases. In the domestic market, generic drugs account for more than 90%, and there are nearly 20 approved preparation manufacturers. After the implementation of volume-based procurement, the terminal price of preparations has dropped by approximately 62%, further promoting the increase of clinical penetration rate. Currently, the registered API suppliers in China are mainly local enterprises, the overall supply pattern is stable, and there is no obvious capacity gap.

The original research enterprise of drotaverine is Laboratoires Fournier S.A. of France, and the original trade name is "Dicetel". Its core compound patent was first applied in France in 1975. The patents in major European markets expired in 1995, and the relevant compound patents in China have also expired. The main dosage form approved for the original drug is tablet, with a specification of 50mg. This product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, more than 10 Chinese enterprises have completed the registration of drotaverine APIs in CDE and obtained the A status label. All the domestic approved drotaverine preparation products are tablets, and multiple enterprises have passed the consistency evaluation of the quality and efficacy of generic drugs. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for drotaverine APIs. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in impurity research, quality control and registration application.