美国通用抗发作药物供应链:美国政府数据库分析的观察结果
Pradeep Javarayee1, Jennifer Meylor1, Shamshad Shahrukh1
1Section of Child Neurology, Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, United States of America.
Seizure
|February 14, 2024
概括
印度主导着仿制抗发作药物 (ASM) 的生产,引发了供应问题. 亲肠道ASM制造有限,供应链数据缺乏透明度.
科学领域:
- 制药供应链分析 制药供应链分析
- 仿制药制造监督监督 仿制药制造监督
- 药物短缺预防策略 药物短缺预防策略
背景情况:
- 全球化和复杂的药物供应链导致制造瓶和药物短缺.
- 了解抗发作药物 (ASM) 供应链的复杂性对于防止短缺至关重要.
研究的目的:
- 分析通用抗发作药物 (ASM) 供应链.
- 专注于生产,标签和重新包装流程.
- 确定制造地点和供应链的漏洞.
主要方法:
- 利用了来自美国食品和药物管理局 (FDA) 和美国国家医学图书馆DailyMed.com的数据.
- 评估ASM配方,制造工厂和标签的供应链细节.
- 分析了2663个NDC-9代码的缩写新药申请 (ANDA) 数据.
主要成果:
- 印度是肠道ASM成品剂型 (FDF) 的首要生产国,拥有49个制造工厂.
- 全球有限的设施存在于亲肠道ASM FDF生产.
- 发现了显著的数据差距,22.7%的ANDA缺乏制造设施标识符;48%的NDC-9涉及重新包装的FDF.
结论:
- 在通用ASM FDF制造方面过度依赖印度,会给供应链带来风险.
- 亲体ASM FDF制造工厂的稀缺性突出了一个关键的脆弱性.
- 由于缺少数据,急需提高ASM供应链的透明度.
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