Last September, the FDA revoked a final approval issued six months earlier to Sun Pharma Advanced Research Co. Ltd. (SPARC), the research division of India’s biggest drug-maker Sun Pharmaceutical Industries Ltd., to launch its anti-seizure drug Elepsia XR. The FDA cited as the reason US regulatory compliance problems at the Halol factory in western Gujarat where the drug was due to be made.
Elepsia XR, a once-a-day formulation of the anti-epileptic drug levetiracetam, was the first drug developed by SPARC to win FDA...
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