Shijiazhuang Sihua Pharmaceutical Group’s theophylline raw material drug has been approved.
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Time:2023-01-19
Recently, the active pharmaceutical ingredient—doxofylline—submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Fourth Pharmaceutical Group, has been approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed formulations. This represents another innovative achievement resulting from Shijiazhuang Fourth Pharmaceutical Group’s proactive implementation of its “API + Formulation” development strategy. It is also the fourth new product approved since the start of the new year, following the approvals of 200ml ciprofloxacin hydrochloride sodium injection, felodipine sustained-release tablets, and lacosamide injection—marking a strong start to the year for R&D innovation.
Recently, the active pharmaceutical ingredient—doxofylline—submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Fourth Pharmaceutical Group, has been approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed formulations. This represents another innovative achievement resulting from Shijiazhuang Fourth Pharmaceutical Group’s proactive implementation of its “API + Finished Dosage Form” development strategy. It is also the fourth new product approved since the start of the new year, following the approvals of 200ml ciprofloxacin hydrochloride sodium injection, felodipine sustained-release tablets, and lacosamide injection—marking a strong start to the year for R&D innovation. 。
It is reported that theophylline is primarily used to treat bronchial asthma, chronic asthmatic bronchitis, and other respiratory difficulties caused by bronchospasm.
Previously, in 2020, Shijiazhuang No.4 Pharmaceutical’s theophylline injection (10mg:0.1g), which had been filed under the new Category 4 regulations, was approved for marketing and was deemed to have passed the consistency evaluation. In February 2021, during the bidding process for the fourth round of national centralized drug procurement, Shijiazhuang No.4 Pharmaceutical’s theophylline injection (10mg:0.1g) won the bid outright. The recent approval of the theophylline active pharmaceutical ingredient will have a positive impact on enhancing the quality and efficiency of this product within the Group.
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