USFDA ISSUES WARNING TO INDIA'S GLENMARK FOR SELLING UNAPPROVED DRUG

Fri. October 16, 2009; Posted: 05:28 AM

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NEW DELHI, Oct 16, 2009 (AsiaPulse via COMTEX) -- GMKPF | Quote | Chart | News | PowerRating -- The US Food and Drugs Administration has issued a warning letter to Mumbai-based Glenmark Pharmaceuticals (BSE:532296) for selling unapproved pain reliever, codeine sulphate tablets, following which the company said it will stop distribution of the drug in America.

In a letter issued on Tuesday to Glenmark's US subsidiary Glenmark Generics Inc USA, the USFDA said the marketing of codeine sulphate 30 mg and 60 mg tablets by the firm in the US violated the Federal Food, Drug, and Cosmetic Act.

When contacted, a Glenmark Pharmaceuticalsspokesperson said, in compliance with the conditions of the warning letter, Glenmark will cease distribution of their codeine sulphate tablets within the timelines indicated by the FDA.

"It must also be noted that this warning letter does not constitute a product recall," he said, adding sales of codeine sulphate tablets were minimal and the impact on Glenmark's financial performance was insignificant.

In its letter, the USFDA said: "Based upon our information, there are no FDA-approved applications on file for the above drug products. The marketing of these products without an approved new drug application constitutes a violation (of the Act)."

While asking the company to respond to its letter within 15 days, the health regulator has given Glenmark 90 days time to stop manufacturing new products and 180 days to stop further shipment of the existing products.

(PTI) bl

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