In a warning letter, the US Food and Drug Administration (USFDA) said the firm failed to establish laboratory controls designed to make sure components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity at its plant.
Alkem Laboratories shares fell over 8 percent intraday Friday on several observations from the US health regulator for Daman facility.
The company will work towards increasing volumes in the gastro-intestinal, anti-diabetic and cardio segments, among others, to overcome margin pressures due to industry headwinds, says Prabhat Agrawal, CEO of Alkem Laboratories.