Sodium Cromoglicate

As a chronic disease with high incidence worldwide, allergic diseases have long been in urgent clinical need of medication options that combine safety and preventive effects. Sodium cromoglicate is an anti-allergic drug belonging to the category of mast cell membrane stabilizers. Its mechanism of action is to stabilize the mast cell membrane and prevent mast cells from releasing inflammatory mediators such as histamine and leukotrienes, thereby inhibiting the occurrence and development of allergic reactions. The clinical indications of this drug cover a variety of allergic diseases such as allergic asthma, allergic rhinitis, spring keratitis, and allergic eczema. It is suitable for patients of all ages who need long-term control of allergic symptoms and reduction of acute attacks. Due to the extremely low incidence of systemic adverse reactions, it is especially suitable for children and people who need long-term maintenance treatment.

As a classic basic anti-allergic drug for clinical use, the global market size of sodium cromoglicate is stable at around USD 320 million, with a steady annual compound growth rate of 2.1%. The core growth driver comes from the continuous rise in the prevalence of allergic diseases. In terms of the domestic market, its preparations have been included in the National Medical Insurance Class B Catalog, and the penetration rate of dosage forms such as atomized inhalation and nasal drops in primary medical institutions is steadily increasing. At present, domestic generic drug preparations have occupied nearly 85% of the domestic market share, and the upstream API supply is dominated by local enterprises. The overall competitive landscape is relatively scattered, and there is no absolutely dominant supplier yet, with the annual production capacity of leading enterprises generally below 100 tons.

The original research enterprise of sodium cromoglicate is Fisons Corporation of the United States, with the original research trade name Intal, and the core compound patent expired globally in 1991. The main dosage forms approved by the original research include inhalation capsules (20mg), nasal drops (4%), eye drops (2%) and oral ointments. Among them, the inhalation capsules have been included in the FDA Orange Book Reference Listed Drug Catalog, and the original research preparations have not been imported into China. According to the domestic API registration platform, a total of 12 enterprises have obtained A-status registration numbers for sodium cromoglicate APIs, which can be used for the association of domestic preparation declarations. In China, 27 enterprises have obtained approval for the marketing of sodium cromoglicate-related preparations, covering multiple dosage forms such as eye drops, nasal drops, and inhalation aerosols. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for sodium cromoglicate, meeting the impurity research needs in the whole process from API research and development to declaration. Most products can be supplied from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be directly used for quality research, stability investigation and submission of registration declaration materials.