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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group Secures Another New Product Approval: Aminophylline Injection Approved
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发布时间：2023-10-31
【概要描述】
Good news arrives in the golden autumn, heralding a triumphant march of innovation. Recently, Shijiazhuang Sihua Pharmaceutical Group’s application for aminophylline injection (10 mL: 0.25 g and 20 mL: 0.5 g) has been approved by the National Medical Products Administration for drug production registration and is deemed to have passed the consistency evaluation.
Good news arrives in the golden autumn, heralding a triumphant march of innovation. Recently, Shijiazhuang Sihua Pharmaceutical Group’s application for aminophylline injection (10 ml: 0.25 g and 20 ml: 0.5 g) has been approved by the National Medical Products Administration for drug production registration and is deemed to have passed the consistency evaluation.
According to available information, aminophylline injection is classified as a Category 3 chemical drug and is primarily used to relieve wheezing symptoms in conditions such as bronchial asthma, chronic asthmatic bronchitis, and chronic obstructive pulmonary disease; it may also be employed in the management of cardiac insufficiency and cardiogenic asthma.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has aligned its strategies with national development goals and market demands, vigorously implementing an innovation-driven development strategy. The company has focused on building an integrated upstream–downstream value chain spanning active pharmaceutical ingredients (APIs) and finished dosage forms, and has actively promoted synergistic development between API production and related formulations. Through sustained and arduous efforts, the group’s R&D capabilities have steadily matured, ushering in a concentrated “harvest period” of innovative breakthroughs. Since October of this year, the group has obtained approval for 10 dosage-form products across 8 product varieties and 10 specifications, as well as approval for one API product, along with approvals for two drug clinical trials involving four specifications across two product varieties. To date, the group has secured a total of 55 approvals for new products this year. Meanwhile, substantial progress has been made in consistency evaluation, with 64 product varieties encompassing 84 specifications now having either passed or been deemed to have passed such evaluations.
The approval of this aminophylline injection (10 mL: 0.25 g and 20 mL: 0.5 g), which is deemed to have passed the consistency evaluation, will play a positive role in further enriching the product portfolio, enhancing the quality and efficiency of both finished dosage forms and active pharmaceutical ingredients, and achieving win-win outcomes.
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