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  • A tough market for new Rosuzet generic
  • by Lee, Tak-Sun | translator Byun Kyung A | Nov 10, 2020 06:06am
Currently 150 items by 50 companies have been approved with substituting evidence submission
Only seven companies directly manufacture drug, others are consigned
 ¡ã Hanmi Pharmaceutical¡¯s rosuvastatin-ezetimibe combination drug Rosuzet
Although the door for generics is to open next year when the post marketing surveillance (PMS) period is terminated for the rosuvastatin and ezetimibe combination drug treating dyslipidemia, the market annually generating 150 billion won is actually not expecting any new generic.

Many of pharmaceutical companies have already received the South Korean health authority by manufacturing drugs on consignments with substituting evidence submission. Only the companies turn the consigned manufacturing to direct manufacturing are conducting bioequivalence test with the reference drug Rosuzet by Hanmi Pharmaceutical after the PMS termination.

The Ministry of Food and Drug Safety (MFDS) reported on Nov. 9 that the mini
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