制剂开发和 CTM 生产

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制剂开发和 CTM 生产

制剂开发和 CTM 生产

方达医药的产品开发和临床试验用药生产团队按照治疗领域的交付要求设计处方、开发GMP生产工艺，以确保生产出高品质的产品用于支持临床试验。.

我们能够提供制剂开发，支持IND（新药临床申请）、NDA（新药上市申请）、ANDA（仿制药）的注册。我们的实验室基于灵活性设计，可以用于各种剂型的研究，并能处理高活性化合物及DEA-管制类药物。

实例： ＞200客户＞200个化合物＞380 GMP批次生产

IND（新药）：口服固体制剂、半固体制剂（局部）、液体制剂、无菌制剂的制剂开发和临床样品生产
ANDA（仿制药）：反向工程、制剂工艺开发及技术转移
消费品：OTC产品的再开发
用于高活性临床试验用药生产的车间
用于无菌临床试验用药（I期）生产的车间
DEA管制类药物的分析和生产许可证（CI-V）
用于验证性的动物试验（PoC）
与方达医药临床中心合作的一体化服务

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