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Last Updated : Oct 29, 2018 12:47 PM IST | Source: PTI

Granules' US unit gets two USFDA observations

"Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US has completed USFDA (US Food and Drug Administration) inspection from October 22-26, 2018 with two Form 483 observations," the company said in a BSE filing.

 
 
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Pharma firm Granules India on Monday said its US subsidiary has received two observations from the US health regulator following the completion of inspection.

"Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US has completed USFDA (US Food and Drug Administration) inspection from October 22-26, 2018 with two Form 483 observations," the company said in a BSE filing.

Granules Pharmaceuticals, Inc will respond to the observations within this week, the company added.

As per the USFDA, a Form 483, is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"This was a prior approval inspection, intended for the Abbreviated New Drug Application (ANDAs) filed by Granules Pharmaceuticals Inc. This facility is involved in development and manufacturing of finished dosages," the company said.

The company's shares were trading 6.74 percent higher at Rs 98.25 apiece on BSE.
First Published on Oct 29, 2018 12:40 pm
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