Drugmaker Glenmark Pharmaceuticals Ltd

葛兰素史克制药有限公司

on Thursday said it has received establishment inspection report from the US health regulator for its formulations manufacturing facility at Monroe, North Carolina, classifying the facility as voluntary action indicated.

周四表示，已收到美国卫生监管机构对其位于北卡罗来纳州门罗的制剂生产设施的设立检查报告，该设施被归类为“需采取自愿行动”。

The inspection was conducted at the company's manufacturing facility from June 9 to June 17, 2025,

检查于2025年6月9日至6月17日在该公司的制造工厂进行，

Glenmark Pharmaceuticals Ltd

格伦马克制药有限公司

said in a statement.

声明中表示。

With this positive development, the company will restart commercial manufacturing at the Monroe site, it added.

该公司补充道，随着这一积极进展，公司将重启门罗工厂的商业生产。

Under Voluntary Action Indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the

在自愿行动指示（VAI）下，尽管在检查期间发现并记录了不良情况，但机构并不准备采取或建议监管行动，根据

USFDA

美国食品药品监督管理局

.

。

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