Ranitidine

Acid-related diseases such as peptic ulcer and reflux esophagitis have long plagued more than 10% of the global population. The advent of histamine H2 receptor antagonists provides a therapeutic option that balances efficacy and economy for the long-term management of such diseases. As a representative drug of the second-generation H2 receptor antagonists, ranitidine significantly inhibits basal gastric acid secretion and gastric acid secretion stimulated by histamine and pentagastrin by competitively blocking H2 receptors on gastric parietal cells. Its acid suppression intensity is 5-8 times that of the first-generation cimetidine, and it has less impact on endocrine and hepatic drug-metabolizing enzymes. It is clinically mainly used for the treatment of gastric and duodenal ulcers, postoperative ulcers, reflux esophagitis, and Zollinger-Ellison syndrome, and can also be used to prevent stress ulcers and the risk of gastric acid inhalation before anesthesia. The applicable population covers adults and children over 8 years old with acid-related diseases.

The global ranitidine market had an annual market size of approximately USD 1.8 billion before the N-nitrosodimethylamine (NDMA) impurity incident in 2019. After the incident, many countries temporarily suspended the marketing of related products in stages. After the impurity risk was eliminated through production process optimization, the market gradually recovered. In 2023, the global market size recovered to USD 920 million, with a compound annual growth rate of 12.7%. Currently, the market is dominated by generic drugs, with original research products accounting for less than 10%. India and China are the world's most important suppliers of ranitidine active pharmaceutical ingredients, with a combined production capacity accounting for 82% of the global total production capacity. In the Chinese domestic market, the oral regular-release dosage forms of ranitidine have been included in the national centralized drug procurement. The winning bid price has dropped by approximately 78% compared with that before the centralized procurement, and the clinical accessibility has been greatly improved.

The original research enterprise of ranitidine is GlaxoSmithKline, and the original research brand name is "Zantac". Its core compound patent expired globally in 1997. The main dosage forms approved for the original research product include tablets, capsules and injections. The common specifications of oral dosage forms are 150 mg and 300 mg, and the specification of injection is 50 mg/2 ml. The original research product has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, there are currently 23 ranitidine API registration numbers from enterprises in regions including Suzhou, Jiangsu and Shijiazhuang, Hebei, among which 18 are in the status of "A" (approved for use in marketed preparations). More than 300 ranitidine-related preparation varieties have been approved for marketing in China, covering multiple dosage forms such as oral and injectable forms. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the needs of impurity research and quality control of ranitidine, CATO can provide a full set of impurity reference standards for this API. 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 the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for enterprises' process optimization, quality research and declaration work.