Bivalirudin for injection obtains marketing authorization from the Australian Therapeutic Goods Administration
May 8, 2025
Source: drugdu
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One May 6, Shuangcheng pharma announced that the company recently received the marketing authorization for bivalirudin for injection issued by the Australian Therapeutic Goods Administration. The drug is used to treat patients with medium- and high-risk acute coronary syndrome (ACS) and can be used in combination with aspirin. Previously, the company had obtained the "Drug Registration Approval" approved and issued by the National Drug Administration for the drug, and passed the National Drug Administration's injection generic drug quality and efficacy consistency evaluation. The Australian marketing authorization will have a positive impact on the company's expansion of overseas markets and improvement of the company's performance. However, the export business of drugs is affected by many factors, and there is uncertainty in the sales time, market size and subsequent expansion progress.
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