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From October, the Indian drug makers will have to pay more for generic filings in the US as the US drug regulator has doubled the fee of Abbreviated New Drug Applications (ANDA)filings.
As per the new Generic Drug User Fee Amendments of 2017 (GDUFA II) the fee for processing ANDAs will see increase of more than USD 100,000, from USD 70,480 in 2017 to USD 171,823 in 2018.
The new rates are going to be applicable from October 1, 2017, through September 30, 2018.
The fee is going to be based on negotiations between the industry and USFDA as part of a new five year reauthorisation of the FDA user fee programs signed into law last month.
