Replies to post #415318 on Elite Pharmaceuticals Inc (ELTP)

[jour_trader]

Excellent insights, thanks. Great to hear that the DMF must be a domestic supplier. Wow, great news all around. 

[Plexigl]

give us a hint …. Does the buyout number end in teen or in a y ?

[mrwrn2010]

Great DD as usual. I'd be interested to hear your numbers/calculations!

[User-827038]

Based on the research I did, there are several approved suppliers of the active pharmaceutical ingredient (API) for Vyvanse (lisdexamfetamine dimesylate) for US drug manufacturers. Here are the key approved suppliers:

Major Approved API Suppliers

Noramco (United States)
Chr. Olesen Group (Denmark)
Embio Limited (India)

Additional Potential Suppliers

While not explicitly confirmed as approved for the US market, these companies are also listed as manufacturers or suppliers of lisdexamfetamine API:
Veranova
Cohance Lifesciences
Tofigh Daru
Alkem Laboratories
Cambrex Corporation
Chattem Chemicals, Inc.
Mallinckrodt Pharmaceuticals
Siegfried AG

Key Details

Noramco, based in the United States, specializes in controlled substance development and manufacturing, including APIs for both opioid and non-opioid products.
Chr. Olesen Group is a European company with a global distribution business and API manufacturing facilities.
Embio Limited is an Indian manufacturer that has been listed as a supplier of lisdexamfetamine API.

Several of these companies have active US Drug Master Files (DMFs) for lisdexamfetamine, indicating their readiness to supply the US markets.
It's important to note that while these companies are listed as manufacturers or suppliers, drug manufacturers in the US would need to ensure that their specific API source is approved by the FDA for use in their generic formulations. The availability of multiple suppliers is expected to increase accessibility and potentially help alleviate shortages of ADHD medications in the US market.

Based on the information that I found, US drug manufacturers do not necessarily need to be domestic suppliers to submit a Drug Master File (DMF) to the FDA.

DMF submission is voluntary and not required by law or FDA regulation.
Both domestic and foreign manufacturers can submit DMFs to the FDA.
However, there is a distinction between domestic and foreign DMF holders:
Domestic DMF holders do not need to appoint a US agent or representative.
Foreign DMF holders are encouraged to engage a US agents.
The FDA accepts DMFs from manufacturers worldwide, as long as they meet the necessary requirements and follow the submission guidelines.
The main purpose of a DMF is to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs.
DMFs can be submitted for various components of drug manufacturing, including active pharmaceutical ingredients (APIs), excipients, packaging materials, and more.
While US drug manufacturers can certainly be domestic suppliers, it is not a requirement for submitting a DMF to the FDA. The key factor is meeting the FDA's guidelines and requirements for DMF submission, regardless of the manufacturer's location.


https://www.fda.gov/drugs/guidances-drugs/drug-master-files-guidelines

I am not an expert in this field. This is just information I found that may be helpful....I am not disagreeing or challenging anyone's research, just trying to help the ELTP team. 😄

[meshcan]

Thanks for all DD Winechemist! My favorite section is this:

"Elite with have at a minimum 2-3 year head start over anyone trying to switch."


GLTA

[Trend-Setter]

Thank you Winechemist, greatly appreciated!

[sharkey1]

THX Winechemist, a blast from the past