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Elite Pharmaceuticals is a specialty
pharmaceutical company principally engaged in the development and manufacture of
oral, controlled release products, using proprietary technology. The Company’s
strategy includes improving off-patent drug products for life cycle
management and developing generic versions of controlled release drug
products with high barriers to entry. Elite’s technology is applicable to
develop delayed, sustained or targeted release pellets, capsules, tablets,
granules and powders.
Elite has two products, Lodrane 24®
and Lodrane
24D®,
currently being sold commercially, and a pipeline of five additional drug
candidates under active development in the therapeutic areas that include pain
management, allergy and infection. Of the products under development, ELI-216, a
once-a-day, abuse deterrent oxycodone product, and ELI-154, a once-a-day
oxycodone product, are in clinical trials and the Company has completed pilot
studies on two of the Registrant’s other generic product candidates. The
Registrant has also submitted an ANDA with Elite’s co-development partner, The
PharmaNetwork, for a pain management generic product. The addressable market
for the pipeline of products is approximately $6 billion. The Registrant’s
facility in Northvale, New Jersey is a Good Manufacturing Practice (“GMP”) and
DEA registered facility for research, development and manufacturing.
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