Elite is waiting for the FDA/DEA to approve their manufacturing facilities for Isradipine & Phendimetrazine.
On 6th June 2011, Elite Pharmaceuticals announced that it had entered into a commercial manufacturing and supply agreement with Mikah Pharma. Under the terms of the agreement, Elite will perform the laboratory stability studies, manufacturing and packaging for two generics: 2.5 mg and 5 mg isradipine capsules, and 35 mg phendimetrazine tartrate tablets. Elite commented that it would be compensated at an agreed-upon transfer price for the manufacturing and packaging of the products. For the isradipine product, Elite will receive a 10% royalty on net profits of the finished products. The company will also receive a onetime milestone payment for each product for the work associated with the technology transfer.