Washington, Sep 18 (UNI) Ranbaxy Laboratories Ltd today announced that they have retained the services of former New York City Mayor Rudy Giuliani and his partners to provide advice and review compliance issues related to the recent United States Food and Drug Administration(FDA) letters and Import Advisory.
Announcing the addition of Mayor Giuliani, Ranbaxy reiterated its commitment to work cooperatively with the FDA to address the Import Advisory and arrange measures which would allow its products identified on the Advisory to be released in the US marketplace.
The company took this action following the US FDA ban on the importation of 28 drugs made by it. These include the generic versions of Cipro, Claritin and Alavert. The bans were due to the manufacturing deficiencies at two plants in India.
Meanwhile, Ranbaxy in a press release said all drugs manufactured by it have been repeatedly tested safe and effective with no adverse incidents reported. It is committed to a swift resolution to address these issues and to continue supply the global marketplace with safe and effective pharmaceuticals.
Director of the Office of Compliance at the Center for Drug Evaluation and Research, Deborah M Autor said ''We believe this step is warranted because of the seriousness and the extent of the violations.'' However,''All the products that we have tested met specifications'' and that there is 'no reason' to consider them as hazardous, she added.
Earlier in July this year federal prosecutors said Ranbaxy ''deliberately misled the US government about the quality of its low-cost medicines.'' Ranbaxy called the allegations 'baseless', in a statement on Monday but said it would cooperate with the investigation.
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