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生物仿制药生产销售商Glenmark Pharma抗炎仿制药获得USFDA批准

Glenmark Pharma gets USFDA nod for generic anti-inflammatory drug

economictimes.indiatimes | 2024-04-29 | 翻译由动脉网AI生成,点击反馈

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Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to sell a generic version of anti-inflammatory drug in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets (250 mg/125 mg), the Mumbai-based drug maker said in a statement.

Glenmark Pharmaceuticals周一表示,已获得美国卫生监管机构的批准,将在美国市场销售仿制药。这家总部位于孟买的制药商在一份声明中表示,该公司已获得美国食品和药物管理局(USFDA)对乙酰氨基酚和布洛芬片剂(250毫克/125毫克)的批准。

The company's product is the generic version of Haleon US Holdings, LLC's Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), it added. Glenmark Therapeutics Inc, USA will distribute the drug in the US market, the drug maker said. According to Nielsen syndicated data for the latest 52 weeks period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg achieved annual sales of around USD 84.1 million.

该公司的产品是Haleon US Holdings,LLC的Advil 2双重作用与对乙酰氨基酚片剂的通用版本,250毫克/125毫克(OTC),它补充道。该制药商表示,美国Glenmark Therapeutics Inc将在美国市场销售该药物。根据尼尔森财团截至2024年3月23日的最近52周的数据,Advil与对乙酰氨基酚片剂250 mg/125 mg的双重作用实现了约8410万美元的年销售额。

Glenmark said its current portfolio consists of 195 products authorised for distribution in the US marketplace and 52 abbreviated new drug applications (ANDAs) pending approval with the USFDA. Shares of Glenmark Pharma were trading marginally up at Rs 1,080.45 apiece on the BSE.(You can now subscribe to our Economic Times WhatsApp channel)(You can now subscribe to our Economic Times WhatsApp channel).

Glenmark表示,其目前的产品组合包括195种授权在美国市场销售的产品和52种正在等待美国FDA批准的缩写新药申请(ANDA)。嘉能可制药(Glenmark Pharma)的股票在BSE上以每股1080.45卢比的价格小幅上涨。(您现在可以订阅我们的经济时报WhatsApp频道)(您现在可以订阅我们的经济时报WhatsApp频道)。

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