Phloroglucinol

For common clinical emergencies such as acute abdominal pain and renal colic caused by smooth muscle spasm, phloroglucinol, as a non-atropine and non-papaverine pure smooth muscle antispasmodic, achieves a balance between efficacy and safety with its unique mechanism of action. It only directly acts on the spasmodic smooth muscle of the gastrointestinal tract, genitourinary tract and biliary tract, has minimal impact on normal smooth muscle, and has no anticholinergic side effects, and will not cause adverse reactions such as hypotension, accelerated heart rate and arrhythmia. It is especially suitable for elderly patients with spastic pain complicated with cardiovascular diseases or glaucoma. Meanwhile, it is also widely used for the relief of uterine contraction pain in obstetrics and gynecology, induced abortion and antispasmodic preparation before endoscopic examination, and is one of the core drugs for the treatment of acute and chronic spastic pain in clinical practice.

At present, the market size of domestic antispasmodic drugs has exceeded 9 billion yuan, among which the growth rate of phloroglucinol has remained above 12% in recent years, making it one of the fastest growing varieties in this therapeutic field. In terms of the competitive landscape, there are more than 30 domestic preparation manufacturers, and the supply of APIs has been in the stage of accelerated domestic substitution for a long time. In 2023, the market share of domestic phloroglucinol APIs has reached 87%. As multiple provinces included it in the centralized procurement catalog in 2022, the demand of preparation enterprises for compliant and stable APIs and impurity reference substances continues to increase.

The original research enterprise of phloroglucinol is Lafon of France, and the original research brand name is "Spasfon". Its core compound patent expired globally in 2009. The dosage forms approved by the original research include injections and oral tablets, among which the injection with the specification of 40mg/4ml is the first batch of reference preparations released in China, and is also included in the FDA Orange Book Reference Preparation Catalog. At present, more than 15 domestic enterprises have obtained Class A status for their phloroglucinol APIs through CDE registration, and the approved preparations cover multiple dosage forms such as injections, suppositories and oral solutions. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of phloroglucinol impurity reference standards, which fully cover all impurity types involved in the synthesis process and degradation pathways. Most of the products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of various links such as API R&D, quality research and consistency evaluation.