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石四药集团(02005)取得国家药监局有关左氧氟沙星滴眼液的药品生产注册批件
Xin Lang Cai Jing· 2025-12-09 06:01
Group 1 - The company has obtained the drug production registration approval from the National Medical Products Administration (NMPA) for Levofloxacin Eye Drops (0.488% (5ml: 24.4mg)), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation [1][2] - Levofloxacin Eye Drops are primarily used for treating eyelid inflammation, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, keratitis, and for sterile chemotherapy during ophthalmic surgeries, enriching the company's ophthalmic product portfolio [1][2] - The company has also announced the approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation [1][2] Group 2 - Compound Magnesium Sulfate Granules are mainly used for bowel cleansing preparation before colonoscopy and X-ray examinations, and can also be used for bowel cleansing before surgical procedures [1][2] - The company's magnesium sulfate active pharmaceutical ingredient has been registered with the NMPA for use in marketed formulations, as noted in the announcement dated December 4, 2025 [1][2]
石四药集团(02005.HK)左氧氟沙星滴眼液取得药品生产注册批件
Jin Rong Jie· 2025-12-09 05:50
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, enhancing its portfolio in the ophthalmic and gastrointestinal preparation sectors [1] Group 1: Product Approvals - The company obtained a production registration for Levofloxacin Eye Drops (0.488% in 5ml, containing 24.4mg), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation. This product is primarily used for treating various eye conditions such as blepharitis, conjunctivitis, and for sterile chemotherapy during ophthalmic surgeries [1] - The company also received approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation. This product is mainly used for bowel cleansing prior to colonoscopy and X-ray examinations, as well as for bowel preparation before surgical procedures [1] Group 2: Raw Material Approval - The company's magnesium sulfate raw material has been approved by the National Medical Products Administration for use in its registered formulations, indicating a solid foundation for its product offerings in the market [1]
石四药集团已取得国家药监局有关左氧氟沙星滴眼液(0.488% (5ml: 24.4mg))的药品生产注册批件
Zhi Tong Cai Jing· 2025-12-09 04:18
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, enhancing its portfolio in the ophthalmic and gastrointestinal preparation sectors [1] Group 1: Product Approvals - The company has obtained a production registration approval for Levofloxacin Eye Drops (0.488% concentration, 5ml: 24.4mg), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation [1] - Levofloxacin Eye Drops are primarily used for treating various eye conditions, including blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, keratitis, and for sterile chemotherapy during ophthalmic surgeries [1] - The approval enriches the company's range of ophthalmic formulations [1] Group 2: Additional Product Approvals - The company has also received approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation [1] - Compound Magnesium Sulfate Granules are mainly used for bowel cleansing prior to colonoscopy and X-ray examinations, and can also be utilized for bowel preparation before surgical procedures [1] - The company's magnesium sulfate active pharmaceutical ingredient has been approved for use in marketed formulations as of December 4, 2025 [1]
石四药集团(02005)已取得国家药监局有关左氧氟沙星滴眼液(0.488% (5ml: 24.4mg))的药品生产注册批件
智通财经网· 2025-12-09 04:15
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, enhancing its portfolio in the ophthalmic and gastrointestinal preparation sectors [1] Group 1: Product Approvals - The company obtained a production registration for Levofloxacin Eye Drops (0.488% (5ml: 24.4mg)), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation [1] - Levofloxacin Eye Drops are primarily used for treating various eye conditions, including blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, keratitis, and for sterile chemotherapy during ophthalmic surgeries [1] Group 2: Additional Product Development - The company also received approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation [1] - Compound Magnesium Sulfate Granules are mainly used for bowel cleansing prior to colonoscopy and X-ray examinations, as well as for bowel preparation before surgical procedures [1] - The company’s magnesium sulfate raw material has been approved for use in its registered formulations as of December 4, 2025 [1]
石四药集团(02005.HK)获左氧氟沙星滴眼液(0.488%(5ml:24.4mg))药品生产注册批件
Ge Long Hui· 2025-12-09 04:12
Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, enhancing its portfolio in the ophthalmic and gastrointestinal preparation sectors [1] Group 1: Product Approvals - The company has obtained a production registration for Levofloxacin Eye Drops (0.488% (5ml: 24.4mg)), classified as a Class 4 chemical drug, which is considered to have passed the consistency evaluation [1] - Levofloxacin Eye Drops are primarily used for treating various eye conditions, including blepharitis, meibomian gland inflammation, dacryocystitis, conjunctivitis, meibomian gland inflammation, keratitis, and for sterile chemotherapy during ophthalmic surgeries [1] - The approval increases the variety of ophthalmic formulations offered by the company [1] Group 2: Additional Product Approvals - The company has also received approval for Compound Magnesium Sulfate Granules (10mg per bag), classified as a Class 3 chemical drug, which is also considered to have passed the consistency evaluation [1] - Compound Magnesium Sulfate Granules are mainly used for bowel cleansing prior to colonoscopy and X-ray examinations, and can also be used for bowel preparation before surgical procedures [1] - The company’s magnesium sulfate active pharmaceutical ingredient has been registered with the National Medical Products Administration for use in marketed formulations [1]
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-12-09 04:01
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示,概不會就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致之任何損失承擔任何責任。 承董事局命 執行董事兼公司秘書 周興揚 香港,二零二五年十二月九日 於本公告日期,董事局成員包括執行董事曲繼廣先生、蘇學軍先生、孟國先生、周興揚先生及 曲婉蓉女士,非執行董事劉文軍先生,以及獨立非執行董事王亦兵先生、周國偉先生及姜廣策 先生。 - 2 - 自願公告 產品開發的最新進展 石四藥集團有限公司(「本公司」,連同其附屬公司,「本集團」)董事局(「董事局」)欣然公告, 本集團已取得中國國家藥品監督管理局(「國家藥監局」)有關左氧氟沙星滴眼液(0.488%(5ml: 24.4mg))的藥品生產註冊批件,屬於化學藥品第4類,視同通過一致性評價。左氧氟沙星滴眼 液主要用於治療眼瞼炎、瞼腺炎、淚囊炎、結膜炎、瞼板腺炎、角膜炎以及用於眼科圍手術期 的無菌化療法。本次獲批使本集團眼用製劑的品種日漸豐富。 董事局亦欣然公告,本集團已取得國家藥監局有關複方匹可硫酸鈉顆粒(每袋含匹可硫酸鈉 10mg),屬於化學藥 ...
复星医药(600196) - 复星医药关于控股子公司获药品注册批准的公告
2025-02-26 08:45
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 剂型:颗粒剂 规格:每袋含匹可硫酸钠 10mg、氧化镁 3.5g 和无水枸橼酸 12.0g 上海复星医药(集团)股份有限公司 关于控股子公司获药品注册批准的公告 一、概况 上海复星医药(集团)股份有限公司(以下简称"本公司")控股子公司苏州 二叶制药有限公司就复方匹可硫酸钠颗粒(以下简称"该药品")的上市注册申请 于近日获国家药品监督管理局批准。 二、该药品的基本情况 证券代码:600196 股票简称:复星医药 编号:临 2025-030 药品通用名称:复方匹可硫酸钠颗粒 根据 IQVIA CHPA 最新数据1,2023 年,复方匹可硫酸钠颗粒于中国境内(不包 括港澳台地区)的销售额约为人民币 783 万元。 四、对上市公司的影响及风险提示 该药品本次获批上市,将进一步丰富本集团产品线。预计该药品本次获批上市 不会对本集团现阶段业绩产生重大影响。 由于医药产品的行业特点,药品上市后的具体销售情况可能受到(包括但不限 于)用药需求、市场竞争、销售渠道等因素影响,具有较大的不确定性。 ...