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FDA Fast-tracked Drugs
The Food and Drug Administration recently approved ASI to manufacture the active pharmaceutical ingredients in the anti-cancer drugs Velcade®, Vidaza®, and Clolar®, drugs to treat multiple myeloma, myelodysplastic syndromes, and leukemia, respectively. These approvals were for FDA fast-tracked drugs, which required us to significantly compress development timelines. All three drugs were approved less than one year from filing a New Drug Application. We believe these approvals are a testament to our superior project management, chemistry and regulatory affairs expertise.
For more information, please see the details of our Development & Manufacturing Facility.
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