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Replies to post #385866 on Elite Pharmaceuticals Inc (ELTP)
The ELTP King
08/23/23 9:39 AM
#385868 RE: WeeZuhl #385866
Concerta is difficult to manufacture, and there are abuse-resistance issues. FDA may expect any generic to at least be as abuse-deterrent as the brand name comparator. So, there are at least two significant hurdles for any company trying to get approval and market generic Concerta.
08/23/23 4:09 PM
#385971 RE: WeeZuhl #385866
imanjen13
08/23/23 4:14 PM
#385972 RE: WeeZuhl #385866
08/26/23 11:39 AM
#386261 RE: WeeZuhl #385866