FDA Warning Letter Blasts Glenmark

Agency Says Firm Consistently Failed To Ensure ‘Effective, Safe’ Products

 
• By Penelope MacRae
  
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Glenmark, which has been the recipient of a string of notices from the US Food and Drug Administration over manufacturing quality issues, is again under fire with the regulator blasting the leading Indian drugmaker for failing to ensure “consistent production” of safe and effective products.

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Glenmark Has Fallen Under The FDA’s Scrutiny • Source: Shutterstock

Glenmark is a repeat offender in the eyes of the US Food and Drug Administration over manufacturing quality issues. But the FDA’s latest warning letter to Glenmark over its Baddi plant in the northern Indian state of Himachal Pradesh may rank as one of its strongest rebukes yet to the Indian drug-maker. The FDA bluntly told Glenmark that its quality control system does not ensure the “consistent production of safe and effective products.”

The comments came in a warning letter raking Glenmark over the coals for failing to properly investigate batch failures at...

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