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Shijiazhuang Sihua Pharmaceutical’s New Product, Terbutaline Sulfate Solution for Nebulization Inhalation, Receives Production Registration Approval

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Honors Announcement

发布时间：2021-04-13

【概要描述】 On April 12, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration for the registration of its Class 4 new chemical drug—terbutaline sulfate solution for nebulization (2 mL: 5 mg)—making it the second domestic manufacturer to obtain such approval, which is deemed equivalent to passing the consistency evaluation.

On April 12, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration for the registration of its Class 4 chemical drug—terbutaline sulfate solution for nebulization (2 mL: 5 mg)—making it the second domestic manufacturer to obtain such approval, which is deemed equivalent to having passed the consistency evaluation.
Terbutaline is a β2-adrenergic agonist that selectively stimulates β2 receptors to induce bronchodilation. It also enhances mucociliary clearance, which is impaired in obstructive lung diseases, thereby accelerating the removal of mucus. Clinically, it is indicated for bronchial asthma, chronic bronchitis, emphysema, and other pulmonary conditions accompanied by bronchospasm.
According to reports, the current domestic market size for terbutaline sulfate solution for nebulization inhalation is approximately RMB 500 million.