Glenmark Pharmaceuticals receives three observations from USFDA for Indore plant

Glenmark Pharmaceuticals has received three observations from the US Food and Drug Administration (USFDA) for its Pithampur, Indore plant, which was inspected by USFDA in February 2016. However, the company has responded to the observations in March 2016.  Subsequently, the company received two product approvals from this plant and the company has no outstanding items with the USFDA regarding this plant.

Glenmark is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity), with seven molecules in various stages of clinical development & pre-clinical development. The company has a significant presence in branded generics markets across emerging economies including India.