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Re: None

Tuesday, 01/22/2019 3:24:23 AM

Tuesday, January 22, 2019 3:24:23 AM

Post# of 403106
So for Elite's generic percocet and norco - Their approval of ANDA came after the April 1st deadline to apply for the QUOTA year 2019. Can they apply ahead of the deadline and saying pending ANDA approval?? I do not know. ELITE WILL DEFINITELY GET THE DEA APPROVAL FOR THE NEXT YEAR which is almost a guaranteed slice of the Perc/Norco pie increasing revenue.
Maybe ELITE is waiting on the Oxy ANDA approval before applying to the DEA>

Elite is a listed as a manufacturer on the DEA's list but I cannot find much info on what they are approved to manufacture. So, I am sure ELITE is applying with the DEA to get the approvals to be a bulk manufacturer for Elites schedule I & II drugs.

Reference info-
Quota requests have deadlines due for the next year’s forecast for manufacturing and packaging by April 1 of each year with DEA response by mid-December. Bulk API manufacturing quota requests should be made before May 1 of each year with the DEA response expected by mid-December as well. Keep in mind that the earlier the quota is requested the better. (Quota Applications, 2018)
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