NMPA approves SinoT’s ANDA application for Bupropion (XL)(150mg,300mg)

Recently, China's National Medical Products Administration (NMPA) approved SinoT’s ANDA application for Bupropion hydrochloride extended-release tablets (XL)(150mg,300mg), this product has already been approved in FDA on August 2017.


Bupropion (XL), an antidepressant of the aminoketone class, are indicated for the treatment of major depressive disorder (MDD) and the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). Compared with Bupropion (SR),which should be taken twice a day, the XL version is taken once a day and released more slowly into body. There’s also a steady amount of medication in your system throughout the day, instead of sudden spikes and dips. This can potentially result in fewer side effects and lesser need to take the medication often.

SinoT is a specialty pharma with focus on the research & development, commercialization and sale of complex generics and 505(b2) products. We dedicated to developing high quality medicines that meet with international standards. We’ll do more than our best to benefit the patients in the future.

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99 Haike Road, Bldg. 3, 1st Flr., Pudong District Shanghai 201210, P.R. China

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No. 163 Zhuhai Road, Haimen Area, Nantong City, Jiangsu Province

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