SPARC Pins Hope On Halol Plant For Elepsia FDA Nod But Has Plan B

25 Aug 2016

• By Penelope MacRae

Sun Pharma’s research arm SPARC says it’s still convinced its Indian parent’s troubled Halol plant offers the shortest route to US regulatory approval for its epilepsy drug Elepsia and its glaucoma medicine Xelpros. US FDA clearances of both drugs have been stalled by manufacturing lapses at Sun Pharma’s factory. But SPARC says it has a manufacturing 'plan B' if necessary.

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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