SPARC Pins Hope On Halol Plant For Elepsia FDA Nod But Has Plan B
Executive Summary
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.
You may also be interested in...
Sun’s Halol Site Out Of Compliance Rut, Could Add Some SPARC Too
Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.
Baclofen Setback Forces Sun R&D Arm Towards Difficult Choices
Sun Pharma Advanced Research Company’s baclofen GRS has failed to meet its primary endpoint in a US Phase III study, posing several tough questions for the firm. It may have to advance partnering plans for some assets and also review its cash flow situation closely.
Sun Acquires Novartis Cancer Drug In Specialty Push
Sun Pharmaceutical Industries Ltd, India’s biggest drug firm, has struck a $175m deal to buy the branded skin cancer drug Odomzo from Novartis, continuing a drive to bulk up on higher-margin specialty products in the face of stiff pricing pressure on the generic front.