Hainan Shuangcheng Pharmaceuticals (002693.SZ): Injection-grade Bortezomib ANDA has obtained market approval from the US FDA.
ST Shuangcheng (002693.SZ) announced that the company has recently received a notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for injection grade Bortezomib has been approved. The FDA conducted a comprehensive technical review of the ANDA application submitted by the company and determined that the company's product is bioequivalent and therapeutically equivalent to the reference drug.
Hainan Shuangcheng Pharmaceuticals (002693.SZ) announced that the company has recently received a notification from the Food and Drug Administration (FDA) of the United States that the Abbreviated New Drug Application (ANDA) for injection of Bortezomib submitted by the company to the FDA has been approved. The FDA conducted a comprehensive technical review of the ANDA application for injection of Bortezomib submitted by the company, and determined that the company's product is bioequivalent and therapeutically equivalent to the original drug.
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