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阿姆内阿尔和Apiject扩大BFS能力以加强美国无菌药物生产

Amneal and Apiject Expand BFS Capabilities to Strengthen U.S. Sterile Drug Manufacturing

PHARMA FOCUS ASIA 等信源发布 2025-05-09 14:11

可切换为仅中文


Amneal Pharmaceuticals and Apiject Systems have announced a strategic partnership to boost domestic pharmaceutical production in the United States.

阿内尔制药公司和Apiject系统公司宣布了一项战略合作伙伴关系,以促进美国国内的制药生产。

The collaboration will expand the use of Apiject’s Blow-Fill-Seal (BFS) injectable platform at Amneal’s facility in Brookhaven, New York.

该合作将扩大Apiject的吹灌封(BFS)注射平台在纽约布鲁克黑文Amneal工厂的使用。

This initiative will increase the capacity to manufacture various sterile drug forms such as prefilled injectables, ophthalmic solutions, and inhalation products. It also supports efforts to improve emergency preparedness and reinforce the U.S. drug supply chain by relocating production to domestic sites..

该举措将提高各种无菌药物形式的生产能力,例如预充注射剂、眼科溶液和吸入产品。通过将生产转移到国内站点,它还支持了改善紧急情况准备和加强美国药物供应链的努力。

Amneal, which already holds a major manufacturing footprint in the country, employs approximately 2,500 people in the U.S., including 800 at the Brookhaven site. The project is expected to generate around 200 new jobs at the facility.

Amneal公司在该国已拥有重要的制造业务,雇用约2,500名美国员工,其中800人在布鲁克黑文工厂工作。该项目预计将在该工厂创造约200个新工作岗位。

As part of the agreement, Amneal will install dedicated production lines to support both government and commercial applications using Apiject’s BFS system. The new infrastructure aims to produce up to 300 million units annually, with the ability to scale beyond 400 million units in the future. The companies will also work together to develop new injectable drug programmes using this technology..

作为协议的一部分,Amneal将安装专用生产线,以支持使用Apiject的BFS系统的政府和商业应用。新设施的目标是每年生产多达3亿个单位,并具备未来扩展至超过4亿个单位的能力。这些公司还将合作利用该技术开发新的注射药物项目。

Apiject’s platform merges BFS manufacturing with injection-moulded needle hubs to produce sterile, single-dose, prefilled devices. This integrated process offers a cost-effective and scalable alternative to traditional glass vials and syringes, with advantages in speed, supply chain efficiency, and sustainability..

Apiject的平台将BFS制造与注塑针头组合相结合,生产出无菌、单剂量、预填充的装置。这一集成工艺为传统玻璃瓶和注射器提供了一种具有成本效益且可扩展的替代方案,在速度、供应链效率和可持续性方面具有优势。

The underlying BFS technology was initially supported by a $180 million investment from the U.S. Department of Health and Human Services during the Trump administration, aimed at enhancing domestic pharmaceutical production during public health emergencies.

底层的BFS技术最初在特朗普政府期间获得了美国卫生与公众服务部1.8亿美元的投资支持,目的是在公共卫生紧急情况下加强国内药物生产。

Apiject fulfilled its role by establishing a reliable fill-finish capacity that could be used in case of supply chain disruptions during the COVID-19 pandemic.

Apiject 通过建立可靠的填充完成能力履行了自己的职责,该能力可以在 COVID-19 大流行期间供应链中断的情况下使用。

Source: amneal.com

来源:amneal.com