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Shijiazhuang Sihua Pharmaceutical Group’s Ketotifen Fumarate Eye Drops and Calcium Gluconate Injection Receive Approval on the Same Day
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发布时间：2025-07-19
【概要描述】
On July 18, Shijiazhuang Sihua Pharmaceutical Group’s two newly developed chemical-drug formulations—the Class 3 ketotifen fumarate ophthalmic solution 0.025% (0.4 ml: 0.1 mg) and calcium gluconate injection (10 ml: 1 g)—both received manufacturing registration approvals from the National Medical Products Administration on the same day and are deemed to have passed the consistency evaluation. Notably, the ketotifen fumarate ophthalmic solution is the second such product in China to be approved.
On July 18, Shijiazhuang Sihua Pharmaceutical Group’s two newly developed chemical-drug formulations—the Class 3 ketotifen fumarate ophthalmic solution 0.025% (0.4 ml: 0.1 mg) and calcium gluconate injection (10 ml: 1 g)—both received manufacturing registration approvals from the National Medical Products Administration on the same day and are deemed to have passed the consistency evaluation. Notably, the ketotifen fumarate ophthalmic solution is the second such product in China to be approved.
To date, the Group has had a total of 139 drug varieties and 185 dosage forms either approved or deemed to have passed the Consistency Evaluation.
According to available information, calcium gluconate injection is indicated for acute hypocalcemia, magnesium toxicity, and fluorosis. Previously, the Group obtained approval for calcium gluconate sodium chloride injection in June 2025. Data from MeneNet show that in 2023, sales of calcium gluconate injection across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 560 million, declining to about RMB 450 million in 2024.
Ketotifen Fumarate Ophthalmic Solution is indicated for the symptomatic treatment of seasonal allergic conjunctivitis. Currently, the Group offers three ophthalmic formulations: Moxifloxacin Hydrochloride Ophthalmic Solution, Timolol Maleate Ophthalmic Solution (0.5% and 0.25%), and Ketotifen Fumarate Ophthalmic Solution. According to data from Menet, in 2023 the combined sales of Ketotifen Fumarate Ophthalmic Solution across the three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—amounted to approximately RMB 10.61 million, rising to about RMB 11.25 million in 2024.
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