Cimetidine

As the first H2 receptor antagonist put into clinical use, the advent of cimetidine has completely rewritten the treatment landscape of peptic ulcer. By competitively blocking H2 receptors on gastric parietal cells, it significantly inhibits basal gastric acid secretion and gastric acid secretion induced by stimulation such as histamine and food, and reduces gastric acid acidity. It is a classic therapeutic drug for acid-related diseases such as peptic ulcer, reflux esophagitis and Zollinger-Ellison syndrome, and can also be used to relieve symptoms such as stomach pain, heartburn and acid regurgitation caused by excessive gastric acid. The applicable population covers adult and pediatric patients with related indications, and long-term clinical application has confirmed its outstanding advantages in safety and economy.

At present, the global cimetidine market has entered a mature development stage. In 2023, the market size was approximately USD 320 million, with a compound annual growth rate maintained at around 1.2%. As the core patents have long expired, the global market is dominated by generic drug supply. China and India are the main producers and exporters of active pharmaceutical ingredients (APIs), and cimetidine APIs produced in China alone account for approximately 65% of the global supply share. In terms of the domestic market, this variety has been included in multiple batches of the national centralized procurement catalog, and the price of winning bid preparations has dropped by more than 80%. Downstream preparation enterprises have sustained and stable demand for cost-effective and compliant APIs, and cost control and registration qualifications have become the core competitive factors for suppliers.

The original research enterprise of cimetidine is GlaxoSmithKline, with the original brand name Tagamet, and its core compound patent expired globally in 1994. The main dosage forms of the original research product include tablets, injections and capsules. Common specifications are 200mg, 400mg and 800mg for tablets, and 2ml:200mg for injections. The original research product has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, currently more than 30 enterprises have obtained A-status registration numbers for their cimetidine APIs. The cimetidine preparation varieties approved for marketing in China cover all dosage forms such as tablets, capsules, injections and oral solutions, with extremely high market accessibility. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of cimetidine impurity reference standards, most of which are in stock. Spot products ordered 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 stable reference standard support for the whole process of API R&D, quality research and declaration.