Main Wockhardt Drug Plant in India Banned by FDA

Main Wockhardt Drug Plant in India Banned by FDA

December 2nd, 2013 // 2:16 pm @

Wockhardt Ltd. is now banned from selling several drugs in the US from another factor in India, after FDA inspectors added it to a restricted list. This caused the company’s stock to drop 14%.

The Wockhardt facility in Aurangabad, which is its highest revenue producer, was added to FDA’s red list last week. This means that the company’s products can be held up without a physical examination.

The plant, which is about 200 miles east of Mumbai, produced $320 million of product for the US market last year, or about 25% of its revenue. This plant makes Toprol XL generic, which is a heart pill that has become very popular in recent years.

Wockhardt stated last week that it has started on several steps to address the FDA observations and is going to resolve the issues as soon as possible.

The Aurangabad factory is the second at that company to be put on an alert list by the agency. Back in May, FDA stated that it would cut down imports from its Waluj plant. The company stated at that time that it would switch production to several other sites, including the plant that has now been restricted.

The FDA import alert also is preventing Wockhardt from making revenue in America from its top products, including Toprol XL.

When the FDA investigators looked at the plant this past summer, they found inconsistent drug test results, urine was coming from open drains, dirty uniforms and mold in a storage area for raw materials.

The import alert comes after the company also failed another FDA audit, where one of its workers was caught trying to hide documents that the agency requested.

This import alert shows how much more attention Indian drugmakers are getting by FDA these days. FDA now is following similar audit practices in that country that it does in the United States.


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