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相关临床试验
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药物批准
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1
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FDA
Food and Drug Administration
- 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.
