Regulatory Authorities In The US Ban Drug Imports From Emcure Pharmaceuticals Ltd, India

by Lakshmi Darshini on  July 20, 2015 at 3:11 PM Drug News
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Drug imports from an Indian manufacturing unit of Emcure Pharmaceuticals Ltd have been banned by the US Food and Drug Administration over violations of standard manufacturing practices. This is the latest in a series of Indian firms to face such an action.
Regulatory Authorities In The US Ban Drug Imports From Emcure Pharmaceuticals Ltd, India
Regulatory Authorities In The US Ban Drug Imports From Emcure Pharmaceuticals Ltd, India
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FDA inspectors observed problems with the company not meeting manufacturing quality standards that could have potentially impacted product sterility.

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Emcure has nine manufacturing plants, including one in the United States. Emcure exports to a number of countries including the US, Europe, Brazil and Japan, according to its website. Emcure is the latest among some of India's largest drugmakers to have come under fire for similar violations in the last few years.

An Emcure Pharma spokesman did not immediately respond to a request for comment. Emcure, which is a marketing partner to large multinational drugmakers such as Pfizer Inc, Roche, Novartis and Sanofi, makes drugs that are mainly used in cardiology, gynecology and to treat infections.

Source: Medindia
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