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21
2 进行中
药物批准
0
批准总数
监管机构
监管机构数
成立时间
N/A
已完成
11
52.4%
尚未招募
2
9.5%
招募中
4
19.1%
暂停
暂无批准数据
- The USFDA classified the July 2026 cGMP inspection of InvaGen Pharmaceuticals' Unit 3 facility in Central Islip, New York, as Voluntary Action Indicated (VAI). - The VAI classification confirms the facility remains largely compliant, avoiding disruptive regulatory actions such as Warning Letters or Import Alerts. - The single Form 483 observation issued during the July 13–17, 2026 inspection was successfully addressed, supporting uninterrupted generic drug supply to the U.S. market. - The outcome removes regulatory overhang for Cipla's U.S. business and keeps the pipeline of pending ANDA approvals from the facility intact.
