Flunisolide

Chronic airway inflammatory diseases such as allergic rhinitis and asthma have long plagued more than 500 million patients worldwide. Glucocorticoid drugs are the core medication for controlling the inflammatory progression of such diseases, and flunisolide is a representative variety with high local anti-inflammatory activity and low systemic adverse reactions. As a synthetic glucocorticoid, it binds to glucocorticoid receptors to inhibit the release of inflammatory mediators, reduce mucosal edema and airway hyperresponsiveness. It is clinically mainly used for the prevention and treatment of allergic rhinitis and bronchial asthma in adults and children over 6 years old. Local administration can greatly reduce the risk of side effects of traditional systemic hormone administration, and it is a commonly used drug in primary diagnosis and treatment and long-term management of chronic diseases.

The global flunisolide market size is approximately USD 320 million, and the compound annual growth rate from 2023 to 2029 is expected to remain at 2.8%. The growth mainly comes from the demand increment brought by the improved diagnosis rate of chronic airway diseases in low-income countries. The current market pattern is dominated by generic drugs, with original research products accounting for less than 15%. China and India are the main suppliers of flunisolide API in the world, accounting for more than 80% of the global API production capacity. Domestic preparations have been included in the local medical insurance Class B catalog, with low terminal prices and high patient accessibility to medication.

The original research enterprise of flunisolide is AstraZeneca, with the original research brand name "Flonase". Its compound patent in the US market expired in 2004, and the core compound patent in China also expired in 2004. The main approved dosage form of the original research product is nasal spray, with a specification of 50 μg of flunisolide per spray. This dosage form has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Listed Drugs for Chemical Drugs* of China. Up to now, 3 domestic enterprises have completed the registration of flunisolide API with the CDE and obtained Class A status, and another 6 domestic flunisolide nasal sprays have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of flunisolide impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of the whole process such as API R&D, quality research, and consistency evaluation.