Good morning Trend-Setter, in my opinion while its a nice idea you are on I do not think that there is any connection between Dexcel and Elite API for either product. I did do some more research, and I strongly feel Elite has a different source of API than most manufacturers if not all. There are currently 3 USA approved, reviewed and active DMFs currently. First a little background, this is a DEA schedule II(2) API, therefore the CFR states that this API cannot be imported and must be manufactured on US soil. The 3 manufacturers that I found were Veranova LP, Noramco and Chattem Chemicals. See the dates and backgrounds below. Now I am 99% sure that Vyvanse, the brand is using Veranova material as based on the DMF date and the NDA approval they coincide. Now almost all generic companies play filings conservative, meaning that they stick with what is proven to work, especially where everyone is trying to get out of the gate at the same time, ie patent expiration date. Therefore, I am 90% certain that almost all of the ANDAs that were approved on the patent expiration date used Veranova's material. Interestingly enough Veranova filed a new DMF on 2023-10-20, see below. Usually an API manufacturer does this in an effort improve the manufacturing process of the API to save both time and money. Based on the dates listed below, I am guessing Elite used either the Noramco, which is an excellent source of APIs or the new Veranova material. Time will tell but I strongly feel we will see the impacts immediately and having JamesF1 in the pharmacy he will be the first one to see if Elite's product gets loaded consistently. To answer another posters question, in order to switch API vendors or even DMF, requires a full Prior Approval Supplment, which is almost like a new ANDA filing. Elite with have at a minimum 2-3 year head start over anyone trying to switch. Either way, all I can say is that I am beyond excited as in my opinion this has potentially propelled us into a way new buyout target price point, one that I do not even want to share as it seems improbable but the numbers in my calculations could support it. Cheers all and when all of this plays out, I am going to hopefully open a winery here in Florida where people can come make their own wine and everyone is invited that's after Vegas of course.
Veranova Lp
U.S.A
Contact
BOS Manchester
Exhibiting
fda
EDQM
WHO-GMP
Veranova: A CDMO that manages complexity with confidence.
Lisdexamfetamine Dimesylate
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 22442
Submission : 2009-01-27
Status : Active
Type : II
Noramco Llc
U.S.A
Contact
American Pharma Summit
Not Confirmed
fda
EDQM
WHO-GMP
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Lisdexamfetamine Dimesylate Drug Substance
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-30
Pay. Date : 2021-11-18
DMF Number : 35645
Submission : 2021-11-23
Status : Active
Type : II
Chattem Chemicals Inc
U.S.A
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American Pharma Summit
Not Confirmed
fda
EDQM
WHO-GMP
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Lisdexamfetamine Dimesylate
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-02
Pay. Date : 2018-05-22
DMF Number : 32289
Submission : 2018-05-18
Status : Active
Type : II
Veranova Lp
U.S.A
Contact
BOS Manchester
Exhibiting
fda
EDQM
WHO-GMP
Veranova: A CDMO that manages complexity with confidence.
Lisdexamfetamine Dimesylate B1625
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-21
Pay. Date : 2023-10-12
DMF Number : 38874
Submission : 2023-10-20
Status : Active
Type : II
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