On 30 September 2019, Hainan Shuangcheng Pharmaceuticals Co. Ltd (the company) received the notification from the U.S. FDA that the ANDA (abbreviated new drug application) of Pregabalin Capsules submit...
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News
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Pregabalin Capsule ANDA Approved by U.S. FDA -
Hainan Shuangcheng Passes U.S. FDA Inspection
Hainan Shuangcheng Pharmaceuticals Co., Ltd (the company) has received the unannounced on-site inspection by the U.S. FDA from 16 April to 24 April 2019, regarding the API, API intermediates and finish...
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Eptifibatide DMF Passes U.S. FDA Review
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...
