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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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