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Bromhexine Hydrochloride Injection Approved—Shijiazhuang Fourth Pharmaceutical Adds Another “Dark Horse” to Its Small-Volume Injectable Product Portfolio.

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Group Announcement

Time：2021-03-26

On March 25, according to the website of the National Medical Products Administration, the Class 3 generic drug—Bromhexine Hydrochloride Injection (2 ml: 4 mg)—submitted by Shijiazhuang No.4 Pharmaceutical Co., Ltd. has been approved for registration and production and is deemed to have passed the consistency evaluation, making it the second company in China to achieve this milestone.
Bromhexine hydrochloride is a mucolytic expectorant that not only dissolves thick mucus but also reduces its viscosity, making it easier to cough up and keeping the airways clear. Clinically, it is primarily used for conditions such as bronchitis, asthma, and emphysema, where thick mucus is difficult to expel.
Currently, the main dosage forms of bromhexine hydrochloride available on the domestic market include injections and tablets. Among these, injections—such as bromhexine hydrochloride glucose injection, bromhexine hydrochloride for injection, and bromhexine hydrochloride injection—enjoy relatively widespread use. Shijiazhuang Sihua Pharmaceutical has obtained production registration approval for bromhexine hydrochloride glucose injection (100 ml: 4 mg bromhexine hydrochloride and 5 g glucose; trade name: Saiwei). Since its launch, this product has been well-received by the market over the years.