Drug firm Granules India today said it has received 11 observations from Portugal's health authority INFARMED for its manufacturing facility located at Gagillapur in Telangana.
INFARMED had conducted a renewal inspection of the facility.
"In this respect, the company has received the inspection report with 11 observations," Granules India said in a regulatory filing.
The plant manufactures pharmaceutical formulation intermediates (PFIs) and finished dosages.
The company said it has initiated necessary steps to address the observations of the inspection agency and will submit its response with a corrective and preventive action plan within the stipulated time.
Besides, the drug firm said, it will also be requesting the INFARMED for re-inspection of the Gagillapur facility at the earliest.
"The company is committed to comply with all the required regulatory requirements and follow the best practices of the industry," it said.
Shares of Granules India today ended at Rs 112.25 apiece on the BSE, up 0.31 per cent from previous close.
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