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位置: 中国 - Zhejiang - 行业- - JIAXING HUAHE PHARMACEUTICAL CO., LTD.

  • 公司名称: JIAXING HUAHE PHARMACEUTICAL CO., LTD.

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  • 行业: 实验室 Laboratory

  • 地址: Room 432-1, Building 1, No. 1 Jinhe Road Qinshan Street, Haiyan County, Jiaxing, ZHEJIANG, 314300 China

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  • Last updated: 2026-03-23

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公司介绍 ：

Huahe Pharma is a China-based radiopharmaceutical CRO & CDMO integrating radioisotope supply, radiolabeling R&D, preclinical imaging, and GMP manufacturing support under one roof. We are the licensed isotope agent of Qinshan Nuclear Power Plant, providing a stable supply of high-purity medical isotopes including Lu-177 (n.c.a.), C-14 labeled compounds, and Mo-99/Tc-99m generators (expected Q2 2026). Radiolabeling & Preclinical Capabilities ● Custom Radiolabeling & Synthesis: Development of Lu-177, I-131, and C-14 radiolabeled small molecules, peptides and biomolecules for biodistribution, PK/PD, and target-binding studies. ● Animal Facility & Imaging Platforms: In-house PET/CT and SPECT/CT systems for mouse and rat studies including biodistribution and dosimetry assessments. ● Dosimetry & Data Analysis: Standardized ROI segmentation and decay-corrected activity calculations using validated software. ● Clinical Translation: In collaboration with the Institute of Radiation Medicine, Fudan University, we can support investigator-initiated trials (IITs) within 6–8 months after tracer PCC confirmation. CDMO & GMP Manufacturing Services ● Process Development & Scale-up: Optimization of radiolabeling and purification processes for clinical and commercial use. ● GMP Production & Aseptic Filling: Qualified hot cells and Class A + C clean rooms for radiopharmaceutical manufacturing and sterile filling. ● Quality Control & Release Testing: Comprehensive QC including radionuclidic purity, radiochemical purity, endotoxin and sterility testing per USP and EP standards. By combining isotope supply, radiolabeling expertise, and end-to-end CRO/CDMO capabilities, Huahe Pharma provides cost-efficient and regulatory-compliant solutions for radiopharmaceutical development from bench to bedside.

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