Sun’s Halol Site Out Of Compliance Rut, Could Add Some SPARC Too
Executive Summary
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.
You may also be interested in...
Sun's Halol Site Faces FDA Action
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.
Sun Site Stares At FDA Action But Dent May Be Limited
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.
Xelpros Approval Adds Spark To Sun’s Site Too?
Xelpros may not be seen as a huge money-spinner, but its approval by the US FDA signals Sun Pharma's expanding interest in the US ophthalmology space. The clearance also potentially indicates that recent compliance issues at the company’s Halol site may not be all-encompassing.