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news.Elite Pharmaceuticals has signed an agreement with an undisclosed Hong Kong-based company (customer) to develop a branded prescription pharmaceutical product in the US.
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As per the agreement, Elite will undertake a developmental program for the product and the customer will provide the formulation for the product.
The customer is responsible for the filing of the new drug application (NDA) for the finished product and the NDA will be filed under the customer’s name.
Elite will hold certain manufacturing rights of the product, upon the NDA approval, and receive milestone payments for the development work.
The marketing and sales of the final product will be taken up by the customer.