Drug firm

药品公司

Wockhardt

沃克哈特

on Monday said the US health regulator has accepted the

周一表示，美国健康监管机构已接受

new drug application

新药申请

(NDA) status for its novel, first-in-class antibiotic

新型一流抗生素的（NDA）状态

Zaynich

扎伊尼奇

.

。

The NDA was filed on September 30, 2025, and its acceptance marks a transformative moment - not only for Wockhardt, but also for the entire

新药申请（NDA）于2025年9月30日提交，其受理标志着一个变革性的时刻——不仅是对沃克哈特，而且对整个行业来说都是如此。

Indian pharmaceutical industry

印度制药行业

, the Mumbai-based drug maker said in a statement.

，这家总部位于孟买的制药商在一份声明中表示。

'This is the first time in history that an NDA for a

“这是历史上首次针对

New Chemical Entity

新化学实体

(NCE) from an Indian pharmaceutical company has been filed and accepted by the

（NCE）已由一家印度制药公司提交并被接受

US FDA

美国食品药品监督管理局

,' it added.

，”它补充道。

Submitting an NDA to the US FDA represents one of the most stringent scientific and regulatory thresholds in global

向美国FDA提交新药申请（NDA）代表了全球最严格科学和监管门槛之一

drug development

药物开发

, the company said.

公司表示。

Zaynich has been granted

扎伊尼奇已被授予

fast-track designation

快速通道指定

by the USFDA, recognising its potential to address urgent and unmet medical needs, it added.

美国食品药品监督管理局（USFDA）认可了其解决紧急且未满足的医疗需求的潜力，并补充道。

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Wockhardt shares were trading 18.93 per cent higher at Rs 1,467 apiece on the BSE.

沃克哈特股票在孟买证券交易所的交易价格为每股1,467卢比，上涨了18.93%。

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