Elite Pharmaceuticals Inc. (OTC:ELTP) Stock In Focus After Filing ANDA with US FDA to Market Central Nervous System Stimulant
Investors are often on the lookout for the latest potential plays in the pharmaceutical sector, and based on the developments from yesterday, Elite Pharmaceuticals Inc. (OTC:ELTP) could well be one to watch out for. The specialty pharmaceutical company is involved in the manufacturing, development, and distribution of generic products from niche segments.
Yesterday, the company announced that the United States Food and Drug Administration had accepted for review its abbreviated new drug application dated December 21, 2023. The application had been made for an undisclosed generic drug from Elite Pharmaceuticals and belonged to a category of medications described as central nervous stimulants. The company also noted in its news release that IQVIA had reported that in the 12-month period that ended in June 2023, the sales in the branded and generic market of the product category stood at $5.1 billion. It was a significant new announcement from the company, considering the potential size of the market that Elite Pharmaceuticals could command by virtue of its product.
The company had come into focus on December 12 when it announced that it had completed the first shipment of its generic Adderall XR product to Prasco LLC, its marketing and distribution partner. In this situation, investors ought to note that Prasco is a Mason, Ohio-based privately held healthcare firm.
However, perhaps more importantly, more than 50 of the best-known and most trusted pharmaceutical companies have used the services of Prasco to bring their products to the generic marketplace in the United States. Adderall XR from Elite Pharmaceuticals has been described as an extended-release mixed salt made up of a solitary Amphetamine product. The companies had reached a supply and manufacturing agreement on April 5, 2023. Prasco would market the products under the Burel Pharmaceuticals brand, and Elite would be responsible for the manufacturing.