Granules India Gets Six Observations From US FDA At Hyderabad Plant
Gagillapur facility is responsible for manufacturing finished dosages and pharmaceutical formulation intermediates.
The US Food and Drug Administration completed its inspection at Granules India Ltd.'s plant in Hyderabad with six observations. The inspection at the Gagillapur facility was conducted from Aug. 26 to Sept. 6, it said in an exchange filing on Saturday.
Gagillapur facility is responsible for manufacturing finished dosages and pharmaceutical formulation intermediates. The inspection covered both current good manufacturing practices and pre-approval inspection processes.
The pharmaceutical company is committed to addressing the observations promptly and will submit its response within the stipulated timeframe, it said.
The company, last month, announced that its subsidiary, Granules Pharmaceuticals Inc., received approval from the US Food and Drug Administration for a generic Glycopyrrolate oral solution.
Shares of Granules India ended 1.43% lower at Rs 687.8 per share on Friday compared to the 1.24% decline in the benchmark BSE Sensex.
