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Three observations have been received by Glenmark Pharmaceuticals from the US health regulator for its Pithampur, Indore plant.
The company, however said that it has responded to the observations issued by the US Food and Drug Administration (USFDA).
Glenmark Pharmaceuticals has said in a regulatory filing that “The Indore plant was inspected by USFDA in February 2016 and we received three observations from them which were responded to in March 2016.”
It further said that subsequently the company received two product approvals from this plant.
The firm has said that “We have no outstanding items with the USFDA regarding this plant.”
