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Shares of Glenmark Pharma tumbled 3 percent in the early trade Tuesday on the back of observations issued by USFDA.
The US Food and Drug Administration (USFDA) has issued 7 observations to company's Baddi units as the company has failed to thoroughly review any unexplained discrepancy and also failure of a batch.
The observations includes, lack of written procedures for production & process controls and complaint records are deficient.
USFDA also mentioned that the records have not maintained so data can be reviewed annually to evaluate quality standards.
It also includes responsibilities & procedures applicable to quality control unit not fully followed, appropriate controls not exercised over computers/related systems and lack of employee training.
The USFDA had inspected Baddi unit from November 6-11.
The Baddi unit manufactures finished dosages and contributing less than 10 percent of total Glenmark’s US sales.
At 09:17 hrs Glenmark Pharma was quoting at Rs 578, down Rs 13.20, or 2.23 percent on the BSE.
Posted by Rakesh Patil
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