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Suzhou Singmed Medical Device Science & Technology Co., Ltd. focuses on the fields of pulmonary, nasal and brain drug delivery devices, and conducts independent intellectual property research and development in the core technology fields of structure design of the drug delivery system , silicon-based atomization development and manufacturing, precision mold and automation, to provide integrated service solutions from structural design, patent FTO, tolerance analysis, medical materials, precision mold, process validation, precision injection molding, product validation and product assembly for the innovative and imitation drug-device combination preparation market.
Suzhou Singmed Industrial Manufacturing Center has 2000 square meters of GMP D/C level (ISO-8 & ISO-7) injection molding and assembly purification workshop, running the world class production equipment (Sumitomo and Fanuc electric injection molding machines, robot assembly, etc.), commercial silicon-based atomizing chip production workshop. The laboratory has independent microbiological test (positive and negative control), microscopic optical examination, inhalation specific NGI test, physical and chemical test, which is qualified to complete the United States Pharmacopoeia standards and China Food and Drug Administration related standard items testing.
The whole process of R&D, design, scale manufacturing and supply chain management meets ISO -13485 medical device design and manufacturing standards, and Singmed's inhalation drug delivery device also fully meets the relevant guidelines for the evaluation of inhalation drug delivery
Suzhou Singmed has cooperated with leading listed biopharmaceutical companies in China to develop and manufacture inhalation and nasal delivery devices commercially for many years, including multi-dose blister DPI devices, single-dose capsule DPI devices, soft mist devices and nasal spray devices.
Suzhou Singmed's two Dry Powder inhalers achieved the first in China to pass the CDE in vivo Consistency Evaluation (official BE) by the China Food and Drug Administration. Soft Mist Inhaler.
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