Glenmark Pharma declines by 3%

The stock of Glenmark Pharma was quoting Rs. 578 per share, down Rs. 13.20, or 2.23 per cent on the BSE at 10:26 hours on Tuesday. The dip in the stock price was on the back of USFDA's negative observations during a recent site inspection.
 
The US Food and Drug Administration (USFDA) inspected the Glenmark Pharma’s Baddi unit from 6 Nov to 11 Nov 2017. The unit manufactures finished dosages and contributes less than 10 per cent to the total Glenmark US sales.
 
As per the USFDA’s observations, the company’s Baddi unit failed to thoroughly review any unexplained discrepancy and also the failure of a batch. The observation includes lack of written procedures for production and process controls and complaints records are deficient.
 
USFDA also mentioned that the company did not maintain data so it can be reviewed annually to evaluate quality standards. Also, the regulator claimed that the company did not comply to the responsibilities and procedures applicable to quality control and appropriate controls were not exercised over computers/related systems and lack of employee training was also among their observations.