Tuesday, September 25, 2012 9:10:08 AM
The second plant -- when you see that coming online, and which products are you looking to push out of there?
it's hard for me to say what that is. But it's a matter of a few months, is our expectation.
In addition to the commercial products, Elite now has 5 products that are pending FDA approval. These products include two ANDAs filed by Elite, two product site transfers, and an ANDA filed by Epic Pharma that is one of the products under the alliance agreement between our companies. The product site transfers include Naltrexone tablets, which is an ANDA purchase by Elite, and phendimetrazine, a product being contract manufactured from Mikah Pharma. Elite has not disclosed the other products.
Regarding patents, a key patent on Elite's opioid abuse resistant technology was allowed and issued recently. This patent covers key know-how regarding technology for creating non-releasing opioid antagonists that can be used in abuse resistant formulations. This is technology used in the development of abuse resistant products in Elite's pipeline. This know-how applies to ANDA opportunities and to NDA opportunities that Elite is working on.
Regarding our facility expansion, an additional piece of equipment is being installed in the packaging line, and once this new piece is in place, the line will be complete. The manufacturing suites are ready now. So after finalization of the packaging line, we will request an FDA inspection and approval of the new area for commercial use. The new warehouse is already in use.
My vision is to create a line of abuse resistant opioid products using our patented technology. Push comes to shove, that's where the value -- the true large value of the Company is
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