Groundbreaking Approval: Taizhou Bay New District Secures Its First Drug Registration Certificate-Kisun Pharmaceutical-Drug products,Healthcare Services

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Groundbreaking Approval: Taizhou Bay New District Secures Its First Drug Registration Certificate

2025-04-08

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Recently, the biopharmaceutical industry development of Taizhou Bay New District took a historic step forward—Zhejiang Kisun Pharmaceutical Co., Ltd. (hereinafter referred to as "Kisun Pharma") successfully obtained the "Drug Registration Certificate" (Drug Approval Number: National Drug Approval H20249655) for its Sitafloxacin Tablets from the National Medical Products Administration.

It is reported that Zhejiang Kisun Pharmaceutical Co., Ltd., located at the intersection of Juhai Avenue and Taizhou Bay Avenue in the Eastern New District, is a high-tech enterprise integrating the R&D, production, and sales of generic drugs. Established on October 17, 2019, it serves as a "pioneer" in the new district's biopharmaceutical sector. The company has already built three tablet production lines and two capsule production lines, all of which are modern workshops compliant with GMP standards.

The approval of the "Drug Registration Certificate" for Sitafloxacin Tablets confirms that Kisun Pharma is qualified to produce and market this drug product, which is expected to positively impact the company's future development. This drug product belongs to the broad-spectrum quinolone class of antibiotics and is used to treat severe, refractory infectious diseases.

During the application process, the Market Supervision Branch of the New District played a crucial role as a communication bridge, providing comprehensive policy guidance and proactive services—from pre-review and document submission to on-site inspection and certificate issuance—ensuring the efficient approval of the drug registration certificate. This successful approval marks the emergence of the first officially qualified drug manufacturer in the new district, filling a critical gap in the local pharmaceutical production landscape and achieving a groundbreaking milestone from "none" to "existence."

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