Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Elite Pharmaceuticals, Inc ( ELTP ) announced today the signing of a license, manufacturing, and supply agreement with Glenmark Pharmaceuticals, Inc., USA to market two Elite generic products in the United States with the option to add products in the future.

Interesting. We've discussed Glenmark before. They were the ones who sponsored Lehigh Valley Pharma efforts to get an NDA for oxycodone 5mg capsules via the 505b2 pathway. Small world, eh? (Or maybe not.)







https://investorshub.advfn.com/boards/read_msg.aspx?message_id=124579915

Next I started trying to track down the fed Tmax for oxycodone tablets, and it turns out that it is not public information, as far as I can find. But! I did find the fed Tmax for oxycodone capsules! I don’t understand the full history of how this happened, but somehow along the way a bunch of generic manufacturers started making oxycodone 5mg in capsule form and oxycodone solution with a different manufacturing technique. They were doing this without proper approvals and the FDA swept them all off the shelf at once, similar to what they did to us with Lodrane. Lehigh Valley (with Glenmark Pharmaceuticals) subsequently received approval for their two products via 505b2 NDA’s for a 5mg capsule- and a second NDA for oral solution. Both NDA’s use Roxicodone as a reference product.