Xinghao Pharmaceutical’s Docetaxel Injection Receives FDA Approval of Abbreviated New Drug Application (ANDA)

May 19, 2025  Source: drugdu 115

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On May 15, Xinghao Pharmaceutical announced that Guangdong Xinghao Pharmaceutical Co., Ltd. recently obtained approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for docetaxel injection. This approval qualifies the company to sell the drug in the U.S. market, marking an important step for the company in expanding overseas markets.

Docetaxel injection is indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer and head and neck cancer. The dosage form is injection with specifications of 80mg/4mL and 20mg/1mL.

In the first quarter of 2025, Xinghao Pharmaceutical achieved revenue of 142 million yuan and net profit attributable to shareholders of the parent company of 25.03 million yuan.

https://finance.eastmoney.com/a/202505153405776677.html

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