FDA Bans Drugs From Two Ranbaxy's Plants

By John Wolper
04:52, September 17th 2008
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FDA Bans Drugs From Two Ranbaxy's Plants

The US health officials has decided to ban certain drugs made by the Indian drugmaker Ranbaxy Laboratories Ltd, after the company failed to meet the U.S. current Good Manufacturing Practice (cGMP) requirements at the manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India.

The decision means that almost 30 different generic drug products manufactured at these plants will no longer be imported in the United States.

In addition, FDA will not approve any new drugs produced at these plants, until the procedural violations will not be solved.

The sole drug excepted from the ban is Ganciclovir oral capsules (an antiviral drug), for which Ranbaxy is the sole supplier to the U.S., FDA has decided to exempt this drug in order to avoid creating a shortage.

Also, the health officials explained that the violations found by FDA investigators earlier this year are regarding the manufacturing process and not the drugs themselves.

That’s why FDA underlined that the patients who are currently taking drugs produced at these two plats should continue their treatment.

However, those patients who are concerned about their medications should discuss their concerns with their health care professional.

FDA has submitted its findings to Ranbaxy and the company has responded in mid-April and May in lengthy submissions to the agency. FDA then evaluated its findings, Ranbaxy's responses, and the firm's overall inspectional history. Ultimately, FDA concluded that the firm's responses were not adequate.

The ban affects widely-used medications, including generic versions of Merck's cholesterol-lowering drug, Zocor, also known as simvastatin, the antibiotic ciprofloxacin, diabetes therapy metformin, cholesterol medicine pravastatin and the over-the-counter version of allergy drug loratadine. The complete list of the drugs affected by FDA’s decision is to be found here.

The agency noted that U.S. shortages of these drugs are unlikely, as other manufacturers will be able to meet consumer demand.



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Tags: FDA, drugs, Ranbaxy
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