ELTP - Elite Pharmaceuticals Announces Supplemental Application for Site Transfer of Isradipine
NORTHVALE, N.J., March 24, 2014 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (ELTP) today announced that on March 21, 2014, the Company filed a Changes Being Effected in 30 Days (CBE-30) supplemental application with the U.S. Food and Drug Administration (FDA) for the site transfer of manufacturing for Isradipine 2.5 mg and 5 mg tablets to Elite's Northvale facility.
Isradipine is one of the twelve products that Elite acquired from Mikah and licensed to Epic Pharma ("Epic") last year. Elite has agreed to manufacture the product for Epic as covered under the Manufacturing and License Agreement between the two companies. Epic will distribute the product as part of the multi-product distribution agreement. The timing of site approval is dependent on the FDA, and no assurances can be given that the site approval will be received in 30 days.
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