Indian generic makers will be watched on Monday after news came out that the US health regulator FDA is hiking the fees for generic drugmakers by up to 48% from October, making Indian generic drugs costlier in America.
Reports said that US regulations require companies to pay user fees to supplement the costs of reviewing generic drug applications.
The FDA said that it is aware that industry is adjusting to the new requirements and fees, and it has minimised the increase in fees "as much as possible
The new Abbreviated New Drug Application (ANDA) fee has been fixed at $ 63,860, which is around 24% higher than the existing $ 51,520, says media report.
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