On February 19, Gelonghui Pharmaceutical (003020.SZ) announced that recently, Hefei Cube Pharmaceutical Co., Ltd. (received the “Notice of Acceptance” of the application for marketing registration of propmecaine hydrochloride raw materials issued by the State Drug Administration.
Promethacaine hydrochloride is a potent ester surface anesthetic. Its preparation, propmecaine hydrochloride eye drops, is clinically mainly used for surface ophthalmic anesthesia, etc., and is a fast-acting local anesthetic. As of the announcement date, the active ingredient for propylmecaine hydrochloride has not yet been registered as an imported API. In addition to the company, five domestic API companies are currently registered. Three of them have a registration status of “A” (raw materials/excipients/packaging materials approved for use in marketed formulations), and two have a registration status of “I” (raw materials/excipients/packaging materials that have not passed the joint review and approval with the formulation).