New Delhi : Glenmark Pharmaceuticals 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 in a regulatory filing.
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.
Glenmark has a significant presence in branded generics markets. It’s subsidiary Glenmark Generics has robust presence in the US business.
The company has 16 manufacturing facilities in five countries and six R&D centres across the globe.
Glenmark shares were trading 0.99 per cent down at Rs 784.20 apiece on BSE.