Dequalinium

During the high incidence period of respiratory tract infections in autumn and winter, local inflammations such as sore throat and oral ulcer are symptoms that are frequently addressed in clinical practice. For the local administration regimens of such diseases, drugs with both safety and rapid effect have been preferred for a long time, and dequalinium chloride is a representative variety among them. It belongs to the broad-spectrum bactericide of cationic surfactant class, exerts its effect by destroying bacterial cell walls and coagulating bacterial proteins, has inactivation effects on Gram-positive bacteria, Gram-negative bacteria and some fungi, and is not easy to induce drug resistance. It is mainly used clinically for the local treatment of acute and chronic pharyngolaryngitis, oral ulcer and gingivitis, and the applicable population covers adults and children without dysphagia. It does not need to undergo systemic metabolism, and the incidence of adverse reactions is extremely low.

As one of the core ingredients of OTC throat medications, the market demand for dequalinium chloride shows a significant growth trend along with the fluctuation of the consultation rate of respiratory diseases. In 2023, the total sales of dequalinium chloride related preparations in domestic public medical institutions and retail terminals exceeded 1.2 billion yuan, with a compound annual growth rate of 18.7% in the recent 3 years. The competition landscape is dominated by generic drugs. More than 20 domestic enterprises have obtained approvals for dequalinium chloride dosage forms such as buccal tablets and sprays. After the centralized procurement, the terminal price of preparations has dropped by more than 60%, which further promotes the increase of the penetration rate in the primary market, and the supply stability of upstream API has become a core consideration for downstream enterprises to expand production.

The original research enterprise of dequalinium chloride is Laboratoire Demapharm in France, and the original research trade name is "Lireng". Its core compound patent expired globally in 1999. The main dosage form of the original research product is buccal tablet with a specification of 0.25mg, which has been included in the China Listed Medicines Catalogue as the reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, 11 domestic enterprises have obtained CDE registration (status A) for dequalinium chloride API, and the approved preparation varieties cover three categories: buccal tablets, sprays and oral patches, which can meet the clinical use demands in different scenarios. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for dequalinium chloride API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide full-chain reference standard support for pharmaceutical enterprises in API R&D, quality research and preparation declaration.