Albendazole

In the field of global worm infection prevention and control, benzimidazole anthelmintics have always been the core clinical medication. As the most representative broad-spectrum agent among them, albendazole irreversibly inhibits the polymerization of cytoplasmic tubulin in parasites, blocks their uptake and utilization of glucose, and ultimately leads to glycogen depletion in worms and impaired ATP production, resulting in their death. It has excellent killing activity against intestinal nematodes such as Ascaris lumbricoides, Enterobius vermicularis, hookworm, Trichuris trichiura, as well as tissue parasites such as echinococcus and cysticercus. Its applicable population covers children over 2 years old and adults. It is the preferred drug for mass deworming programs recommended by the WHO, and also the core medication for rural health governance and food-borne parasite prevention and control in China.

At present, the annual global market size of albendazole preparations is approximately USD 860 million, with a compound annual growth rate of 4.2% in the past 3 years. The demand growth mainly comes from bulk procurement for parasitic disease prevention and control projects in tropical regions, as well as the expansion of deworming demand in the animal husbandry and aquaculture industry. China is the world's largest producer of albendazole API, with an annual output accounting for more than 75% of the total global supply. The domestic preparation market has completed generic substitution after patent expiration, and the public medical institution sector has included it in the national centralized procurement. The price of the selected products has dropped by more than 80% compared with the originator product, and the accessibility at the primary level has been greatly improved.

The originator enterprise of albendazole is GlaxoSmithKline, with the originator brand name "Zentel". The core compound patent expired globally in 1999. The marketed originator dosage forms mainly include 0.2g tablets, 0.4g capsules and 100mg/5ml oral suspensions. Its 0.2g tablet has been included in both the Chinese Catalog of Reference Preparations for Chemical Drugs and the FDA Reference Preparation Catalog. According to the domestic API registration platform, 23 enterprises' albendazole APIs have been registered with the CDE and approved for marketing so far, and there are more than 160 domestic preparation approvals, covering tablets, capsules, granules and other dosage forms. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for albendazole quality control and generic drug consistency evaluation, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock. Spot products ordered before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia and the FDA, and can fully support enterprises to complete the whole process of R&D and quality control work such as API related substance testing and preparation stability research.