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阿勒姆比克制药公司收到美国FDA关于肿瘤配方设施的EIR

Alembic Pharmaceuticals Receives EIR from US FDA for Oncology Formulation Facility

Medgate Today 等信源发布 2025-05-01 20:22

可切换为仅中文


Alembic Pharmaceuticals Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Oncology Formulation Facility (Injectable and Oral Solid), located at Panelav.

Alembic Pharmaceuticals Limited 宣布,已收到美国食品药品监督管理局 (US FDA) 针对其位于 Panelav 的肿瘤制剂工厂(注射剂和口服固体)发出的设施检查报告 (EIR)。

This follows the successful completion of a US FDA inspection conducted at the facility from October 7 to October 8, 2024, as communicated in earlier intimation.

这得益于该设施于2024年10月7日至10月8日成功完成的美国FDA检查,正如早前通知中所述。

The receipt of the EIR signifies the closure of the inspection process and reinforces Alembic’s commitment to global regulatory compliance and high-quality manufacturing standards.

收到最终检查报告标志着检查程序的结束,并重申了Alembic对全球法规遵从性和高质量制造标准的承诺。