Famotidine

The global incidence of acid-related diseases such as peptic ulcer and gastroesophageal reflux disease has long remained at the level of 10% to 20%, and acid-suppressive drugs are the core medications for the clinical treatment of such diseases. Famotidine is a third-generation H2 receptor antagonist, which competitively blocks H2 receptors on gastric parietal cells to inhibit basal gastric acid secretion and gastric acid secretion induced by stimulation of food, histamine and other factors. Its acid-suppressive intensity is 20 times that of cimetidine and 7.5 times that of ranitidine, and it has no anti-androgen effect with fewer drug interactions. Clinically, it can be used for the treatment of gastric and duodenal ulcers, stress ulcers, acute gastric mucosal bleeding and gastrinoma, and can also be used for reflux esophagitis and pre-anesthesia administration to prevent aspiration pneumonia, applicable to adult and pediatric patients with acid-related diseases.

The current global market size of famotidine preparations is approximately USD 1.4 billion, and the Chinese market is approximately RMB 1.8 billion. In recent years, due to the increase in the consultation rate of digestive diseases and the expansion of over-the-counter medication scenarios, the market size has maintained a steady growth rate of around 3%. Domestic generic drug substitution has been completed. There are more than 200 approvals for existing famotidine preparations, 30 enterprises have passed the consistency evaluation, and the average winning bid price of oral dosage forms included in the national centralized procurement catalog has dropped by more than 70% compared with the maximum price limit. The API supply side is dominated by Chinese and Indian enterprises. There are 12 domestic API enterprises with legal production qualifications. The total domestic output of famotidine API in 2023 was approximately 1,300 tons, of which nearly 40% was used for export.

The original developer of famotidine is Yamanouchi Pharmaceutical Co., Ltd. of Japan (now Astellas Pharma), and the original brand name is "Gaster". Its core compound patent expired globally in 2001. The dosage forms of the original drug approved in China include tablets, injections and granules. The specification of tablets is 20 mg, that of injections is 20 mg/2 ml, and that of granules is 20 mg per bag. The original product has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. 12 valid registration numbers of famotidine API can be found on the domestic API registration platform, among which 8 are in A status and can be used for associated declaration by preparation enterprises. The domestically approved and marketed famotidine preparations cover three categories: oral regular-release dosage forms, injections and granules, meeting the medication needs of different clinical scenarios. (Data as of December 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for famotidine, fully covering impurities from the synthesis process, degradation impurities and impurities related to preparation processes. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are regularly in stock, and spot orders submitted before 16:00 can be shipped on the same day, which can provide stable reference material support for API R&D, quality research and consistency evaluation work.