Eptifibatide DMF Passes U.S. FDA Review

2017-11-02 16:54
According to the updated information of the US FDA on 27 October, as the table indicted below, the DMF of Eptifibatide electronically submitted by Hainan Shuangcheng has passed the assessment review on 20 October, and now it is “Available for Reference”.
That is, the user fee has been paid, and the DMF can be referenced for the ANDA submission. It will facilitate the international promotion and sales of the company's API.

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