Elite Pharmaceuticals Inc (QB) (ELTP) Quote

Actually the regulation you cited does not explicitly prevent Vyvanse from being manufactured outside the United States.
The regulation (§1312.12) states that controlled substances in Schedules I and II cannot be imported into the U.S. unless the importer is properly registered and obtains a DEA permit.
This means that Vyvanse can be manufactured outside the U.S. and imported into the U.S. legally if:
The foreign manufacturer is registered with the DEA.
The U.S.-based importer obtains the necessary DEA import permit and complies with all requirements under the Controlled Substances Act.

Text from regulation with key parts bolded
No person shall import, or cause to be imported, into the customs territory of the United States from any place outside thereof (but within the United States), or into the United States from any place outside thereof, any controlled substances listed in Schedule I or II, or any narcotic controlled substance listed in Schedule III, IV, or V, or any non-narcotic controlled substance listed in Schedule III which the Administrator has specifically designated by regulation in § 1312.30 or any non-narcotic controlled substance listed in Schedule IV or V which is also listed in Schedule I or II of the Convention on Psychotropic Substances, 1971, unless and until such person is properly registered under the Act (or, in accordance with part 1301 of this chapter, exempt from registration) and the Administration has issued him or her a permit to do so in accordance with § 1312.13.

Yes, it does, thank you HGilS

Welcome back to the board, King !!!!!!!!!!!!!!!!!

Your DD has been missed,

IB_🤴

You need to understand what you read ..................

Day'Um,

IB_🤴

This is my source on code for fed regulation stating Schedule II's cannot be imported regarding importation of controlled substances:

https://www.ecfr.gov/current/title-21/chapter-II/part-1312/subject-group-ECFRc11ae182f37bc43

Dude. How many fucking bridges you got? This is insane. Gonna start calling you Jeff.

Nice articles, but none addressed whether Schedule II drugs can be imported. They can be exported as mentioned, but still not sold on the idea that Schedule II's can be imported. 

No, Adderall and Vyvanse do not have to be manufactured in the USA to be sold in the local market [A](https://pharmaphorum.com/sales-marketing/adhd-medication-scarcity-adds-questions-us-supply-chain?copilot_analytics_metadata=eyJldmVudEluZm9fY29udmVyc2F0aW9uSWQiOiJIM0xudFByYVdrcXhuR0tGdUtOUG4iLCJldmVudEluZm9fY2xpY2tEZXN0aW5hdGlvbiI6Imh0dHBzOlwvXC9waGFybWFwaG9ydW0uY29tXC9zYWxlcy1tYXJrZXRpbmdcL2FkaGQtbWVkaWNhdGlvbi1zY2FyY2l0eS1hZGRzLXF1ZXN0aW9ucy11cy1zdXBwbHktY2hhaW4iLCJldmVudEluZm9fbWVzc2FnZUlkIjoibXUyR3VudThwRFVLYW1YQjR2NTZ2IiwiZXZlbnRJbmZvX2NsaWNrU291cmNlIjoiY2l0YXRpb25MaW5rIn0%3D&citationMarker=9F742443-6C92-4C44-BF58-8F5A7C53B6F1). These medications can be produced internationally, but they must meet the stringent quality and regulatory standards set by the U.S. Food and Drug Administration (FDA) [A](https://pharmaphorum.com/sales-marketing/adhd-medication-scarcity-adds-questions-us-supply-chain?copilot_analytics_metadata=eyJldmVudEluZm9fY29udmVyc2F0aW9uSWQiOiJIM0xudFByYVdrcXhuR0tGdUtOUG4iLCJldmVudEluZm9fbWVzc2FnZUlkIjoibXUyR3VudThwRFVLYW1YQjR2NTZ2IiwiZXZlbnRJbmZvX2NsaWNrU291cmNlIjoiY2l0YXRpb25MaW5rIiwiZXZlbnRJbmZvX2NsaWNrRGVzdGluYXRpb24iOiJodHRwczpcL1wvcGhhcm1hcGhvcnVtLmNvbVwvc2FsZXMtbWFya2V0aW5nXC9hZGhkLW1lZGljYXRpb24tc2NhcmNpdHktYWRkcy1xdWVzdGlvbnMtdXMtc3VwcGx5LWNoYWluIn0%3D&citationMarker=9F742443-6C92-4C44-BF58-8F5A7C53B6F1). The active pharmaceutical ingredients (APIs) and finished products are often manufactured abroad, particularly in countries like India and China [A](https://pharmaphorum.com/sales-marketing/adhd-medication-scarcity-adds-questions-us-supply-chain?copilot_analytics_metadata=eyJldmVudEluZm9fbWVzc2FnZUlkIjoibXUyR3VudThwRFVLYW1YQjR2NTZ2IiwiZXZlbnRJbmZvX2NvbnZlcnNhdGlvbklkIjoiSDNMbnRQcmFXa3F4bkdLRnVLTlBuIiwiZXZlbnRJbmZvX2NsaWNrU291cmNlIjoiY2l0YXRpb25MaW5rIiwiZXZlbnRJbmZvX2NsaWNrRGVzdGluYXRpb24iOiJodHRwczpcL1wvcGhhcm1hcGhvcnVtLmNvbVwvc2FsZXMtbWFya2V0aW5nXC9hZGhkLW1lZGljYXRpb24tc2NhcmNpdHktYWRkcy1xdWVzdGlvbnMtdXMtc3VwcGx5LWNoYWluIn0%3D&citationMarker=9F742443-6C92-4C44-BF58-8F5A7C53B6F1).

However, the production of these drugs is closely monitored by the FDA and the Drug Enforcement Administration (DEA) due to their classification as Schedule II controlled substances [B](https://arstechnica.com/science/2024/09/adhd-drug-gets-23-5-production-boost-from-dea-amid-shortage/?copilot_analytics_metadata=eyJldmVudEluZm9fY29udmVyc2F0aW9uSWQiOiJIM0xudFByYVdrcXhuR0tGdUtOUG4iLCJldmVudEluZm9fbWVzc2FnZUlkIjoibXUyR3VudThwRFVLYW1YQjR2NTZ2IiwiZXZlbnRJbmZvX2NsaWNrRGVzdGluYXRpb24iOiJodHRwczpcL1wvYXJzdGVjaG5pY2EuY29tXC9zY2llbmNlXC8yMDI0XC8wOVwvYWRoZC1kcnVnLWdldHMtMjMtNS1wcm9kdWN0aW9uLWJvb3N0LWZyb20tZGVhLWFtaWQtc2hvcnRhZ2VcLyIsImV2ZW50SW5mb19jbGlja1NvdXJjZSI6ImNpdGF0aW9uTGluayJ9&citationMarker=9F742443-6C92-4C44-BF58-8F5A7C53B6F1). This means there are strict quotas and regulations in place to control their production and distribution to prevent abuse and ensure supply meets legitimate medical needs [B](https://arstechnica.com/science/2024/09/adhd-drug-gets-23-5-production-boost-from-dea-amid-shortage/?copilot_analytics_metadata=eyJldmVudEluZm9fY29udmVyc2F0aW9uSWQiOiJIM0xudFByYVdrcXhuR0tGdUtOUG4iLCJldmVudEluZm9fY2xpY2tEZXN0aW5hdGlvbiI6Imh0dHBzOlwvXC9hcnN0ZWNobmljYS5jb21cL3NjaWVuY2VcLzIwMjRcLzA5XC9hZGhkLWRydWctZ2V0cy0yMy01LXByb2R1Y3Rpb24tYm9vc3QtZnJvbS1kZWEtYW1pZC1zaG9ydGFnZVwvIiwiZXZlbnRJbmZvX21lc3NhZ2VJZCI6Im11Mkd1bnU4cERVS2FtWEI0djU2diIsImV2ZW50SW5mb19jbGlja1NvdXJjZSI6ImNpdGF0aW9uTGluayJ9&citationMarker=9F742443-6C92-4C44-BF58-8F5A7C53B6F1).

Does this help clarify things for you?

I understood that both Adderall and Vyvanse are schedule II drugs, which means they must be manufactured in the US. 

The fda has several drugs categories. Some categories have to be manufactured in the USA like opioids. But adderall and Vyvanse are not. Must be linked to addiction
———
There aren't specific categories of drugs that are outright banned from being manufactured outside the USA. However, the FDA has stringent regulations and quality standards that must be met for any drug, whether manufactured domestically or internationally, to be sold in the U.S. market. This includes both brand-name and generic drugs.

The complexity of the pharmaceutical supply chain means that many active pharmaceutical ingredients (APIs) and finished drugs are produced abroad, particularly in countries like India and China. However, certain high-risk or highly regulated drugs, such as those used in critical care or with narrow therapeutic indices, might be more closely monitored and subject to stricter manufacturing controls.

For more detailed information, you can check out [this report](https://www.cidrap.umn.edu/report-details-where-top-100-brand-name-rx-drugs-are-made).

Does this help with what you were looking for?

Some here have said API has to manufactured here but nothing on the web (ChatGPT or googles AI) supports that. They clearly say that some pharmaceutical ingredients (APIs) for Adderall are manufactured outside of the United States. The APIs are primarily produced in China and India.

This website clearly states that stimulants like Adderall and its generic versions are often produced abroad, making them vulnerable.

https://www.techtarget.com/pharmalifesciences/feature/The-Policy-Problem-Behind-Adderalls-Pharmaceutical-Supply-Chain-Crisis

So now I am confused.

Sinking ship, Kool aide is getting more bitter and bitter. Don't worry, the buyout is around the corner. It has to be, the ceo is near retirement. Bagholders never learn from otc fantasy dreams. I got a new bridge to sell you all.

Your point is 100% correct ................

I would not waste time debating The Board Contrarian ......... "They/The" !!!!!!!!!!!!!!!!!!!!

IB_🤴

Seems simple for drugs though, IMO. If a company manufactures their drugs in the USA- 15% tax. Supplies / ingredients purchased from USA suppliers 15% pass thru cost. Supplies / ingredients / drugs purchased from non-USA suppliers will have already been tariffed @ %?%?. I'm guessing USA pharm companies will charge prices depending on each drugs availability- Supply / demand pricing rather than passing on their tax savings across the board.

Your conflating manufacturing something complex like a car with drug manufacturing. Cars can have things like doors and their entire engines manufactured in Mexico and shipped to the US to stick on the base platform (that could also be manufactured outside of US). That manufacturing is relatively easy to game in that most of the jobs associated with manufacturing are overseas and not here. It doesn't take many people to stick doors and completely built engines in a car frame. The final assembly of these 'big parts' almost fully automated these days.

The concept of drug manufacturing is pretty straight forward and has never included the development of API or molding the plastic bottles the pills are put in. Although our experts here say all API for controlled substances must be created in US so that makes most of Elite's profitable products home grown.

How can a capsule be partially manufactured elsewhere? And I suppose they could separate making the pills/capsules from packaging but I bet that increases costs.

So it will be interesting to see how it plays out.

I may be mistaken, but I thought controlled substances already had to be manufactured in the us. Is that incorrect?

Purdue can’t pay their lawyers.

The complexity of what is/isn't manufactured here would be unreal to decipher. What about assembled in US vs manufactured? Would love for this to be a tailwind for us, but I think it's easier said than done. I think big companies will get carved out as there will be loopholes. There always are.  Will be interesting to see how this plays out over next few months and how much incremental inflation is created.

To avoid the tariffs for a given product I would think that product needs to be manufactured in the US. So Adderall that is not manufactured in the US would get a tariff. Meaning anything imported into the US that didn't get manufactured here would get a tariff. While companies have some manufacturing here they probably don't have some of all products they sell manufactured here. The bottles coming in from off shore get a tariff. The ones they produce here don't. Such companies still experiences extra costs. In addition the infrastructure for controlled substances has an extra cost. Elite's is a nice facility focused on such drugs and has brand new infrastructure and facilities. So I disagree with you and continue to think this threat by Trump if it comes to fruition will pay off nicely for us.

Your tottally right Kayak, this could work out very well for Elite, the courts are fed up with them.

Elite can benefit greatly if it gets tax advantages from the government for manufacturing in the USA !!!!

Purdue made billions on the illegal sales and those are pocketed profits. The Purdue lawyers of course want to claim Purdue can't pay the fines for killing a bunch of people and ruining the lives of even more unless they can maintain a monopoly on the drug they illegally marketed. I doubt the courts will buy that argument. Purdue has plenty of revenue and assets from past profits. Plus such a monopoly for no reason except to keep a company profitable so it can cover court imposed fines is going to face legal challenges.

Plus, I doubt Trumps DOJ would want to help the Sackler family. Trump has been pretty vocal about drug issues and the Sackler's are not billionaires that can help Trump personally in any way. So I think he would like to stick it to them.

ChatGPTs thoughts on the matter
Any decision that results in a monopoly or prevents generic drugs from entering the market would likely face scrutiny from the Federal Trade Commission (FTC) or Department of Justice (DOJ) for antitrust violations.
It is theoretically legal for a court to allow a monopoly in specific, exceptional circumstances, such as ensuring payment of court-imposed fines or restitution. However, this would face significant legal and ethical scrutiny. Courts would need to justify such a decision by showing that it serves the public interest, is temporary, and is narrowly tailored to achieve the specific objective of compensating victims or creditors. Any such decision would likely be controversial and could prompt appeals or challenges from regulators or other affected parties.

Not sure how this will benefit Elite. Some companies do business domestically and internationally. I don't think there will actually be any financial benefit for Elite. I think it's all smoke & mirrors. 

I'm not sure that we have any competitors that don't already have manufacturing operations in the US.

For example, Teva is headquartered in Israel, but has global production plants, including several in the US. 

Trump is going to reward Elite for manufacturing in US and punish companies who do not manufacture here

In his virtual address to the World Economic Forum in Davos this morning Trump announced plans to impose tariffs on companies that manufacture goods outside the United States and to offer tax advantages to those that produce domestically.

This will give Elite investors two ways to profit
1. Elite will have an advantage in cost to manufacture that they can either use to increase market by selling for less than competitors that manufacture outside the US or to increase profits by keeping the price the same but having lower manufacture costs.

2. Elite's going to become very attractive as a buyout target for companies needing to be able to claim manufacturing capabilities to avoid tariffs. The next year or two could be an ideal time for Nasrat to get a very good price for the company.

That was part of argument at that time.

Imanjen, I saved this link from a couple years ago

https://news.bloomberglaw.com/ip-law/purdue-warns-oxycontin-copies-launch-would-imperil-opioid-deal

Basiclly it says, Purdue wont pay if there are copies of Oxy.
So we are not privvy to the fine print of the settlement, just yet.

Make that 500 mill. up front cash and you got a deal.

In the settlement the Sackler family agreed to divest itself from Purdue. I wonder if that has any effect on the outstanding litigation with Elite. The minutes may give a clue to where this is going but my gut tells me that the parties asked the Court to extend the stay.

Elite should tell Purdue we'll take a check for $250 million to not pursue Generic OxyContin any longer.

Thanks.

The Sacklers and Purdue Pharma boosted their settlement contribution to $7.4 billion after the U.S. Supreme Court overturned a prior settlement in June 2024. If approved, the new plan would end the costliest corporate bankruptcy resulting from the U.S. opioid crisis.

The company and the once-prominent family behind the drug OxyContin agreed Thursday to increase their financial contribution to resolve mass opioid litigation.

Now maybe we find out what was said in that missing 11 minutes, from yesterday

A longer version through the AP,
https://apnews.com/article/purdue-pharma-sackler-settlement-opioid-lawsuits-ea6c89aa9cafc8fdd18fabfad503eeea

says Trump won't interfere with the Supreem's
let it be so

Have seen this myself numerous times in the past. For me, it was near instantaneous (like a .0001 bid over mine), which makes me think some type of algorithmic trading is happening to let them hop over our bids.

Purdue just agreed to a new settlement. 7.4 billion opioid

https://www.aol.com/purdue-pharma-sackler-family-owners-182909956.html?guccounter=1&guce_referrer=aHR0cHM6Ly9zZWFyY2gueWFob28uY29tLw&guce_referrer_sig=AQAAANGdo4D3Yq8cI5_jjgwwTtnec8L5Ogw9TbJ1gKZRDqMkbhkPqs6XSsE4mT2jPi5lW9idZpLF12u3XO6LZMrcUIYUEhuewzIgCSV-9cbuoOLR8dlHuW812DrqGlp3Yde6V4Yf2UUx1zH29QV384y6TZ00dynrpjesyymhoMwfIW95

I was able to pick up a few more. Thanks again. Not advice.

I agree with you, Snup !!!!!!!!!!

Why do you think management does not promote the stock to attract new investors ????????????

Supply & Demand ...... we need more buyers............

The Church of nasrat members is constantly chirping "Manipulation", "Manipulation" yet they never seem to ask why nasrat does not promote the stock to combat this,

IB_🤴

HenryB3, we've addressed your Poop-flavored "Kook Aide". Each day when you try to sell your bridge. Unfortunately your bridge has no support. Why would anyone buy your negative-perspective bridge when you can't support it with any facts about $ELTP? Of course $2 is achievable by January 2026. There's a higher likelihood that it will happen before that - because of the available facts, and progress Elite Pharmaceuticals has made. See? A supported bridge. A bridge that actually leads somewhere. Perhaps try investing in something successful, rather than trying to hawk a weak bridge daily to kool aide Poop-Town? Common sense - ya know? 🚀💰️

Certain market makers work partners the one shorting having an agreement once they get down to where they have their profit they want then the other market maker that will buy it and then play it along so again then with the longs get their percentage they want towards the end of the run up The other market maker who wants to short it, buys in and then shorts it all the way down it’s a teeter totter effect and they use it on us for the past forever

I'm still lurking with $212k to spend from my Roth. Just waiting for the bear raids. Someone trigger it!

Wow, $2 kool aide now? And now its 2026? keep pushing that buyout price up and years out. Soon everyone will have unloaded. Don't be left being a bagholder. Be better, drink less kool aide with artificial sweetners, and don't think that bridge is coming soon.

I’m not sure what it means, if anything. I put a 50,000 bid at .475, which was the highest bid at the time, and seconds later there was a bid at .4751.

THX. Hgiils, good read, everybody knows Elite is way under valued, She won’t be flying
under the radar much longer.

CANT WAIT. for the Feb. financials.

What are you talking about!? The actions short sellers take to mitigate risk, such as buying back shares to cover or hedging with call options, typically lead to increased demand and higher stock prices.

I think it’s the 1.5 million shorts trying to cover before next week

https://www.defenseworld.net/2025/01/23/contrasting-scopus-biopharma-nasdaqscps-elite-pharmaceuticals-otcmktseltp.html#google_vignette

I think the drop in price is related to the uncertainty associated with Trump's surprise freeze of all communication from federal health agencies. No one knows what it means or how long it will last. Veruy happy we aren't waiting to hear anything from the FDA that is meaningful to us in the next few months. We are waiting for BEs of needle movers which depends on independently contracted studies and has nothing to do with federal agencies. Although I have no clue as to whether a new drug launch requires any communication from the FDA. They have to update their 'color' books with the new drug manufacturer information, but I think that happens after the drug is launched and doesn't prevent it.

The crazy train has departed the station, make sure your seats are in the upright position and your seat belt is securly fastened cause we are going to go for a wild ride...choo, choo, choo!

Lots of articles on the topic you can find for yourselves. ChatGPT's high level assessment after slurping many of those in is

In summary, while the temporary pause in health communications requires additional approvals for public releases, it is not expected to directly affect the FDA's internal review process for new drugs. Nonetheless, the potential for delays in public communications related to drug approvals cannot be entirely ruled out.

IB I believe I read last cc where our CEO largest shareholder seems content with 50 cents price, and it feels like stock is actively knocked down here
What perplexes me more is how many current posters which I recognize seems to have held all these years and are happy with 3 runs from what 2014? To 70 twice and 90 cents range once, I can't get around we are now a growth stock without the valuation and r content with not changing our approach to potential new retail investors? Our heightened goals should be dollar land and attracting institutions/tires to us yet elite seemingly hasn't internally moved up to this mindset yet?

Sadly Snup, I'm not sure this is every shareholder's goal: "Also our goal has always been NASDAQ and taking out the dollar PPS not 50 cents range!" ............

Many years ago, when ELTP traded north of $0.10, it seems a shareholder made a comment about $0.03 per share and ELTP fell to that level and stayed down around there for YEARS ............. It seems like that same shareholder recently mentioned something about ELTP at $0.50 per share, seems like that is about where we are, how long this time ?????????????

Why do you expect that shareholder would mention this ????????????

IB_🤴