美国林业发展局将Sun Pharma的印度工厂标记为违反安全规定,推迟药物批准。 U.S. FDA flags Sun Pharma’s Indian plant for safety violations, delaying drug approvals.

美国FDA在2025年9月8日至19日进行检查后,将位于古吉拉特的Sun Pharma的Baska制造设施归类为官方行动指示 (OAI),理由是对良好的制造实践的遵守问题存在重大问题. The U.S. FDA has classified Sun Pharma’s Baska manufacturing facility in Gujarat as Official Action Indicated (OAI) after an inspection from September 8 to 19, 2025, citing significant compliance concerns with good manufacturing practices. 分类可能会拖延待决药物申请的批准,直至问题得到解决。 The classification may delay approval of pending drug applications until issues are resolved. 孙药业证实了OAI的地位,并表示它继续向美国市场提供批准的产品,并正在与FDA合作解决调查结果. Sun Pharma confirmed the OAI status, stating it continues to supply approved products to the U.S. market and is working with the FDA to address findings. 该公司的股份在宣布之后下跌了2.38%。 The company’s shares fell 2.38% following the announcement. 审调处的状况反映了正在进行的监管审查,但并未停止目前的药物供应。 The OAI status reflects ongoing regulatory scrutiny but does not halt current drug supplies.