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Bromhexine Hydrochloride Injection Approved, Adding Another “Dark Horse” to Shijiazhuang Sihua Pharmaceutical’s Small-Volume Injectable Portfolio

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Honors Announcement

发布时间：2021-03-26

【概要描述】 On March 25, the website of the National Medical Products Administration announced that Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s application for Class 3 generic bromhexine hydrochloride injection (2 mL: 4 mg) has been approved for registration and manufacturing, and is deemed to have passed the consistency evaluation, making it the second such product in China.

On March 25, the website of the National Medical Products Administration announced that Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s application for Class 3 generic bromhexine hydrochloride injection (2 mL: 4 mg) has been approved for registration and manufacturing, and is deemed to have passed the consistency evaluation, making it the second such product in China.
Bromhexine hydrochloride is a mucolytic expectorant that not only dissolves viscous sputum but also reduces its viscosity, thereby facilitating expectoration and maintaining airway patency. Clinically, it is primarily used for conditions such as bronchitis, asthma, and emphysema, in which thick, sticky sputum is difficult to expel.
Currently, the main dosage forms of bromhexine hydrochloride available on the domestic market are injections and tablets, with injections—including bromhexine hydrochloride glucose injection, injectable bromhexine hydrochloride, and bromhexine hydrochloride injection—being more widely used. Shijiazhuang Sihua Pharmaceutical Co., Ltd. has obtained the production registration approval for bromhexine hydrochloride glucose injection (100 mL: 4 mg of bromhexine hydrochloride and 5 g of glucose; trade name: Saiwei), and the product has enjoyed strong market acceptance since its launch several years ago.