FDA reviewing Ranbaxy corrective action plan
US health regulator FDA is working on a corrective action plan submitted by Ranbaxy Laboratories after 30 medicines of company manufactured at two of its plants in India were banned from exporting to America.
By PTI |
NEW DELHI: The US health regulator Food and Drug Administration (FDA) is working on a corrective action plan submitted by Ranbaxy Laboratories after 30 medicines of the company manufactured at two of its plants in India were banned from exporting to America.
"The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the US market are safe and effective," US FDA spokesperson Christopher C Kelly said in a response to an e-mailed query.
"(The) FDA received the Corrective Action Operating Plan (CAOP) from Ranbaxy on May 18, 2009. The CAOP is currently under review by the Center for Drug Evaluation and Research's Office of Compliance," the regulator said.
The next steps will be dependent on the actions identified on the CAOP, it added.
Ranbaxy's new CEO Atul Sobti on Sunday said that the company has submitted a corrective plan to the US FDA.
The US health regulator on September last year had banned the import of 30 generic drugs, manufactured at company's plants located in Dewas in Madhya Pradesh and Poanta Sahib in Himachal Pradesh, alleging fraudulent practice.
Ranbaxy official could not be contacted for comments.
"The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the US market are safe and effective," US FDA spokesperson Christopher C Kelly said in a response to an e-mailed query.
"(The) FDA received the Corrective Action Operating Plan (CAOP) from Ranbaxy on May 18, 2009. The CAOP is currently under review by the Center for Drug Evaluation and Research's Office of Compliance," the regulator said.
The next steps will be dependent on the actions identified on the CAOP, it added.
Ranbaxy's new CEO Atul Sobti on Sunday said that the company has submitted a corrective plan to the US FDA.
The US health regulator on September last year had banned the import of 30 generic drugs, manufactured at company's plants located in Dewas in Madhya Pradesh and Poanta Sahib in Himachal Pradesh, alleging fraudulent practice.
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Ranbaxy official could not be contacted for comments.
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