Benzydamine

As an indole derivative among non-steroidal anti-inflammatory drugs, benzydamine exerts anti-inflammatory, analgesic, antipyretic and local anesthetic effects by inhibiting prostaglandin synthesis and stabilizing lysosomal membranes, with no risk of addiction. It is clinically mostly used for relieving inflammatory pain such as postoperative pain, soft tissue injury and rheumatoid arthritis. It can also be administered through the oral mucosa to treat local inflammations such as oral ulcers and pharyngitis. The applicable population covers patients in postoperative recovery period, patients with chronic inflammatory diseases and people with oral mucosal diseases. Local topical preparations have a high acceptance rate in the treatment of mild diseases in elderly and pediatric patients due to their mild adverse reactions.

The global market size of benzydamine is approximately USD 210 million, and the compound annual growth rate from 2023 to 2028 is expected to be 3.8%. The growth mainly comes from the expanded demand in the fields of oral local inflammation medication and postoperative analgesia. The market structure is dominated by generic drugs. European pharmaceutical companies account for about 42% of the production capacity share, and domestic enterprises are gradually seizing the Asia-Pacific and Latin American markets by virtue of their cost advantages. There is no record of national centralized procurement of this variety in China, and the generic drug application is still in the early stage, and there is no market situation of monopoly by leading enterprises.

The original research enterprise of benzydamine is Chiesi Pharmaceuticals of Italy, and the original brand name is "Yanbiling". The core compound patent expired worldwide in 1985. The originally marketed dosage forms include benzydamine hydrochloride tablets (25mg, 50mg), oral mouthwash (0.15%), and topical cream (5%). Among them, the 0.15% oral mouthwash and 50mg tablets have been included in the FDA Reference Listed Drug Catalogue, while the original research products have not yet been included in the *Catalogue of Reference Preparations for Chemical Drugs* in China. At present, there is no approved A status registration number of benzydamine on the domestic API registration platform, and only 1 enterprise is in the stage of application and review. The only approved and marketed preparations are benzydamine hydrochloride oral mouthwash and topical spray. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for benzydamine, covering all categories such as synthetic process intermediates, degradation impurities and isomer impurities. Most products are in sufficient stock. Spot orders submitted before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable and compliant reference standard support for generic drug research and development, quality research and routine production quality control.