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Glenmark gets 3 FDA observations
Highlights
Glenmark Pharmaceuticals on Thursday said it has received three observations from the US health regulator for its Pithampur, Indore plant. However, the company said it has responded to the observations issued by the US Food and Drug Administration (USFDA).
New Delhi : Glenmark Pharmaceuticals on Thursday said it has received three observations from the US health regulator for its Pithampur, Indore plant. However, the company said it has responded to the observations issued by the US Food and Drug Administration (USFDA).
"The Indore plant was inspected by USFDA in February 2016 and we received three observations from them which were responded to in March 2016," Glenmark Pharmaceuticals said. Subsequently the company received two product approvals from this plant, it added.
"We have no outstanding items with the USFDA regarding this plant," the Mumbai-based firm said. The Pithampur-based formulations facility manufactures oral solids, semi solids and injectables.
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