Good News! Shijiazhuang Sihua Pharmaceutical Group’s Doxapram Hydrochloride Injection (5 ml: 100 mg) Has Been Approved
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发布时间:2026-03-09
【概要描述】
Good news on a festive occasion heralds a new chapter of innovation. On March 3, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug—Doxapram Hydrochloride Injection (5 ml: 100 mg)—received production registration approval from the National Medical Products Administration and is deemed to have passed the consistency evaluation, making the company the first in China to obtain approval for this product. Since the beginning of this year, the Group has secured approval for nine new products.
Good news on a festive occasion heralds a new chapter of innovation. On March 3, Shijiazhuang Sihua Pharmaceutical Group’s Class 3 chemical drug—Doxapram Hydrochloride Injection (5 mL: 100 mg)—received production registration approval from the National Medical Products Administration and is deemed to have passed the consistency evaluation, making the company the first in China to obtain approval for this product. Since the beginning of this year, the Group has secured approval for nine new products.
According to available information, doxapram hydrochloride injection is indicated for respiratory failure.
In recent years, the Group has continuously intensified its R&D efforts in specialty generic drugs, shortage medications, rare-disease treatments, innovative drugs, complex formulations, and specialty active pharmaceutical ingredients, with the number of specialty generic drug applications submitted and approved ranking among the highest in the industry.
Since the beginning of this year, four new dosage-form products have been successively approved: Perindopril Amlodipine Tablets (III), Potassium Dihydrogen Phosphate Injection (2 mL), Propafenone Hydrochloride Injection (20 mL: 70 mg), and Doxapram Hydrochloride Injection (5 mL: 100 mg). Notably, Doxapram Hydrochloride Injection (5 mL: 100 mg) was the first in China to be approved under the new chemical drug registration classification, while Propafenone Hydrochloride Injection (20 mL: 70 mg) is the third such product to receive approval.
To date, the Group has had a total of 169 drug varieties and 221 dosage forms either approved or deemed to have passed the Consistency Evaluation, with a steady stream of innovative achievements being translated into practical applications, continuously injecting new momentum into the company’s high-quality development.
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