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仿制Breezhaler吸入器
仿制Breezhaler吸入器
仿制Breezhaler吸入器

仿制Breezhaler吸入器

更新时间:2026-02-27

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地区: 苏州市
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产品名称: 仿制Breezhaler吸入器
产品分类: 吸入剂包装
产品关键词: 单剂量吸入器
是否为生产商:
主要销售市场: 中国

产品描述:

1.    新劢德自研产品 This product is independently designed and developed by Singmed.

2.    单剂量胶囊型DPI  Single Dose Capsule DPI

3.    新劢德设计与制造的装置已与中国多家头部上市制药企业开展生物等效性研究(采用诺华的三种药),已实现与原研装置的可替换。The self-developed Breezhaler® designed and manufactured by Singmed has been conducting Bioequivalence Researching (loaded with Indacaterol/Glycopyrronium Bromide/Indacaterol Maleate and Glycopyrronium Bromide produced by NOVARTIS) with a number of Chinese leading listed pharmaceutical companies, and has realized the replacement of the novel device.

4.    新劢德仿制装置规避了原研的专利限制,在保持与原研产品相同空气动力学机理的情况下,形成了新的设计和专利。

The generic device developed by Singmed circumvents the patent restrictions of the novel product, incorporating an innovating design and gaining our own patent while maintaining the same aerodynamic mechanism as the original product.

公司简介

苏州新劢德医疗器械科技有限公司聚焦肺部给药,鼻腔给药和眼科给药器械领域,在给药系统的结构设计、硅基雾化开发与制造,精密模具与自动化等核心技术领域进行自主知识产权研发,为创新与仿制的药械组合制剂市场,提供从结构设计、专利FTO、公差分析、医疗材料、精密模具、工艺验证、精密注塑、产品验证和产品组装等一体化服务解决方案。苏州新劢德工业化制造中心具有8000平方米GMP D/C 级别(ISO-8 & ISO-7)的注塑与装配净化车间,运行世界一流的生产设备(日本住友和发那科全电动注塑机,机器人装配等),商业化硅基雾化芯片生产车间,具有独立的微生物检验(阳性与阴性对照),显微光学检查,吸入专用NGI测试,物理化学检验的实验室,可以完成美国药典标准和中国药监局相关标准项目检测。从研发设计、规模制造和供应链管理全流程满足ISO-13485医疗器械设计与制造标准, 新劢德的吸入给药装置也完全满足美国FDA发布的相关吸入给药制剂评价指导原则。苏州新劢德与中国头部上市生物制药公司实现了多年的吸入装置和鼻腔给药装置的商业化开发与制造,涵盖多剂量泡罩型DPI装置,单剂量胶囊型DPI装置、软雾装置和鼻腔喷雾装置等。苏州新劢德的两款干粉雾化吸入装置(Dry Powder Inhaler)(如:噻托溴铵粉雾剂单剂量胶囊型和乌美溴铵维兰特罗吸入粉雾剂泡囊型)实现了中国首家通过中国药监局CDE体内一致性评价(正式BE);柔雾给药装置(Soft Mist Inhaler)(如:噻托溴铵喷雾剂)实现了中国首家通过体内一致性临床评价。
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1.    新劢德自研产品 This product is independently designed and developed by Singmed.2.    单剂量胶囊型DPI  Single Dose Capsule DPI3.    新劢德设计与制造的装置已与中国多家头部上市制药企业开展生物等效性研究(采用诺华的三种药),已实现与原研装置的可替换。The self-developed Breezhaler® designed and manufactured by Singmed has been conducting Bioequivalence Researching (loaded with Indacaterol/Glycopyrronium Bromide/Indacaterol Maleate and Glycopyrronium Bromide produced by NOVARTIS) with a number of Chinese leading listed pharmaceutical companies, and has realized the replacement of the novel device.4.    新劢德仿制装置规避了原研的专利限制,在保持与原研产品相同空气动力学机理的情况下,形成了新的设计和专利。The generic device developed by Singmed circumvents the patent restrictions of the novel product, incorporating an innovating design and gaining our own patent while maintaining the same aerodynamic mechanism as the original product.
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1.    新劢德自研产品 This product is independently designed and developed by Singmed.2.    单剂量胶囊型DPI  Single Dose Capsule DPI3.    新劢德设计与制造的装置已与中国多家头部上市制药企业开展生物等效性研究(采用诺华的三种药),已实现与原研装置的可替换。The self-developed Breezhaler® designed and manufactured by Singmed has been conducting Bioequivalence Researching (loaded with Indacaterol/Glycopyrronium Bromide/Indacaterol Maleate and Glycopyrronium Bromide produced by NOVARTIS) with a number of Chinese leading listed pharmaceutical companies, and has realized the replacement of the novel device.4.    新劢德仿制装置规避了原研的专利限制,在保持与原研产品相同空气动力学机理的情况下,形成了新的设计和专利。The generic device developed by Singmed circumvents the patent restrictions of the novel product, incorporating an innovating design and gaining our own patent while maintaining the same aerodynamic mechanism as the original product.
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1.    新劢德自研产品 This product is independently designed and developed by Singmed.2.    单剂量胶囊型DPI  Single Dose Capsule DPI3.    新劢德设计与制造的装置已与中国多家头部上市制药企业开展生物等效性研究(采用诺华的三种药),已实现与原研装置的可替换。The self-developed Breezhaler® designed and manufactured by Singmed has been conducting Bioequivalence Researching (loaded with Indacaterol/Glycopyrronium Bromide/Indacaterol Maleate and Glycopyrronium Bromide produced by NOVARTIS) with a number of Chinese leading listed pharmaceutical companies, and has realized the replacement of the novel device.4.    新劢德仿制装置规避了原研的专利限制,在保持与原研产品相同空气动力学机理的情况下,形成了新的设计和专利。The generic device developed by Singmed circumvents the patent restrictions of the novel product, incorporating an innovating design and gaining our own patent while maintaining the same aerodynamic mechanism as the original product.
苏州新劢德医疗器械科技有限公司
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