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.
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Sun’s key specialty asset Ilumya makes progress, albeit slowly, in the US, while the firm sees ‘short window’ to ensure that Absorica LD gains grip in that market ahead of impending arrival of generic.
An FDA warning letter issued to Aurobindo highlights recurring failures over several sites, while Teva is setting up a biologics development campus in the US and Nexus is investing in sterile injectables capacity.