Posts Tagged "glenmark"

Warning Letter to Glenmark for Selling Unapproved Drug

Posted on Mar 22, 2010 in Uncategorized

Submitted by Amit Pathania on Wed, 03/17/2010 – 10:47 Pharmaceutical Sector Featured Health TNM Glenmark   On Tuesday, the Food and Drug Administration warned Glenmark Pharmaceuticals Ltd. for selling nitroglycerin tablets without approval. FDA said, “Based upon our information, there are no FDA-approved applications on file for nitroglycerin tablets in doses of 0.3 milligrams, 0.4 milligrams and 0.6 milligrams”. However, Glenmark said that nitroglycerin was an old drug that was earlier “grandfathered” with a group of medicines sold in the United States before the...

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