USFDA blocks imports from Ranbaxy for poor quality

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New Delhi, Sep 17 (UNI) The US government has blocked the import of more than 30 generic drugs including popular antibiotics and cholesterol medicines made by Ranbaxy, country's biggest pharmaceutical company, citing poor quality in two of its factories.

The US Food and Drug Administration's (USFDA) move does not end US sales by Ranbaxy Laboratories Ltd. Instead, it blocks import of generic drugs, including generic versions of the antibiotic Cipro and cholesterol pill Zocor, as well as pharmaceutical ingredients made at the two suspect plants.

''Inspections by the USFDA this year found violations that could lead to contamination, allergic reactions and other problems, and the company has not taken proper steps to correct them,'' USFDA Compliance Office Director Deborah Autor said.

Also, the FDA said it will not approve new products for sale by Ranbaxy until the manufacturing violations are corrected.

India has become one of the world's leading suppliers of generic drugs, and concern about Ranbaxy has been growing since USFDA inspectors uncovered quality problems at one of its factories in 2006.

Among the blocked drugs: the antibiotics ciprofloxacin and clarithromycin; the antiviral acyclovir; cholesterol-lowering simvastatin and pravastatin; and the diabetes drug metformin.

The move is separate from a continuing criminal investigation of whether Ranbaxy submitted fraudulent data to the FDA that allowed sale of substandard drugs.

Ranbaxy has denied that allegation vigorously, calling it part of a conspiracy to undermine the company.

The factories with defects are in Dewas and Paonta Sahib.


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