Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

Okay... got it... DEA quotas for schedule I and schedule II (Adderall as and example).

https://www.fdli.org/2018/08/update-the-dea-quota-system/

Controlled Substances Listed in Schedule I and II
For controlled substances listed in Schedule I and II, DEA sets three quotas: the Aggregate Production Quota (APQ),4 Manufacturing Quotas (MQ),5 and
Procurement Quotas (PQ).6
Unless otherwise stated, all quotas that will be discussed are for each basic class of controlled substance listed in Schedules I and II. Pursuant to 21 C.F.R. § 1300.01(b), basic class essentially encompasses all the chemical forms of the drug. For example, morphine is the basic class which encompasses all salt forms of morphine, including but not limited to morphine hydrobromide, morphine hydrochloride, and morphine sulfate.

It continues.....

Good question for the up coming CC. What is the APQ, MQ, and PQ for this particular CNS drug? Particularly the PQ and when is this quota given?
If there is a quota previously given and approval is delayed does this quota transfer to the new PDUFA date? Or is it reassigned a new quota?