US FDA Flags Glenmark's Indore Plant With 'Official Action Indicated' Tag

Glenmark Pharmaceuticals Ltd. late Friday said the US Food and Drug Administration has classified its Indore manufacturing facility as "official action indicated" following an inspection in February.

The US FDA had conducted a good manufacturing practices inspection from February 3 to February 14 and issued a Form 483 with five observations. The classification means the regulator is recommending regulatory or administrative actions, according to the FDA website.