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New rules for Indian generic drug makers

All generic drug makers, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories and Lupin, are now required to pay a fee to the US drug regulator while seeking permission to launch their......
  Web results for Gdufa
TROUBLE WORSENING FOR EXPORTERS

Pharmaceutical export from India continues to be in trouble with the growing global competition and recurrent regulatory actions against some of... ...

http://www.pharmabiz.com/ArticleDetails.aspx?aid=83971&sid=3
US FDA posts draft guidance on correspondence related to GDUFA Amendments

Outlines communication process between industry and agency US FDA published a notice in the Federal Register announcing the availability of a new... ...

http://pharma.financialexpress.com/latest-updates/4344-us-fda-posts-draft-guidance-on-correspondence-related-to-gdufa-amendments
86 generic drug approvals voluntarily withdrawn

Drug companies in the US are carefully evaluating their portfolios to give away approvals for those products that are not commercially viable, as... ...

http://www.moneycontrol.com/news/business/gdufa-fee-86-generic-drug-approvals-voluntarily-withdrawn_1114178.html

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