US FDA bans Emcure Pharma’s India plant over manufacturing issues

The U.S. Food and Drug Administration has banned drug imports from an India manufacturing unit of Emcure Pharmaceuticals Ltd over violations of standard manufacturing practices, the latest in a series of Indian firms to face such action.

In an ‘import alert’ posted on its website on Monday, the FDA said it had barred imports from Emcure’s Hinjewadi manufacturing plant in Maharashtra after an inspection revealed the company was not meeting manufacturing quality standards.

The company has nine manufacturing plants, including one in the United States, and exports to a number of countries including the U.S., Europe, Brazil, and Japan, according to its website.

Emcure, one of India’s top 20 drugmakers, is the latest among some of India’s largest drugmakers to have come under fire for similar violations in the last few years, hurting the country’s reputation as a reliable supplier of cheap generic drugs to the world, and impacting the growth of the $15 billion industry.

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: Reuters)

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