| STATUS |
Change in Law in the early 1990s has had a tremendous impact on the generic drug industry. USA's generic drug manufacturers traditionally obtained 80% of their API from Europe. The new law bars European API producers from supplying samples to customers in the generic drug industry until patents on the branded drugs actually expire, even if the customers are outside Europe. This new law has been unacceptable to generic drug manufacturers, because obtaining regulatory approvals to sell new generic compds takes 2-3 years. Therefore generic drug manufacturers need samples 2-3 years before patents expire, so as to be able to enter the market as soon as the law allows. As a consequence there is huge market coming up because European API manufacturers were going to lose their advantage |
| UPDATE | 02.00 |
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