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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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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
Two Specifications of Single-Dose Timolol Maleate Ophthalmic Solution Approved for Shijiazhuang Sihua Pharmaceutical Group
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发布时间：2025-06-10
【概要描述】
On June 9, Shijiazhuang Sihua Pharmaceutical Group’s applications for two single-dose ophthalmic formulations—timolol maleate eye drops, 0.5% (0.3 mL: 1.5 mg) and 0.25% (0.3 mL: 0.75 mg), classified as Chemical Drug Category 3—were the first to receive approval from the National Medical Products Administration, thereby being deemed to have passed the bioequivalence evaluation for generic drugs.
On June 9, Shijiazhuang Sihua Pharmaceutical Group’s applications for two single-dose ophthalmic formulations—timolol maleate eye drops, 0.5% (0.3 ml: 1.5 mg) and 0.25% (0.3 ml: 0.75 mg), classified as Chemical Drug Category 3—were the first to receive approval from the National Medical Products Administration, thereby being deemed to have passed the bioequivalence evaluation for generic drugs.
To date, the Group has had a total of 175 product specifications across 130 varieties that have either passed or are deemed to have passed the Consistency Evaluation.
According to available information, timolol maleate ophthalmic solution is effective in reducing intraocular pressure in primary open-angle glaucoma; in certain cases of secondary glaucoma, ocular hypertension, and some forms of primary angle-closure glaucoma, as well as in glaucoma that has failed to respond to other medications and surgical interventions, the use of this product can further enhance the intraocular-pressure–lowering effect.
Over the past two years, Shijiazhuang Sihua Pharmaceutical Group has aligned its strategies with market demand, accelerated innovation-driven development, and actively explored new avenues in ophthalmic formulations. Following the successful launch of moxifloxacin eye drops, the company has now successfully developed single-dose, preservative-free timolol maleate eye drops, thereby enriching its portfolio of ophthalmic products and further strengthening its competitive edge through product differentiation.
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Non-Commercial (Filing) – 2025-0091