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苑东生物(688513.SH):盐酸尼卡地平注射液获得美国 FDA药品注册批准

Chengdu Easton Biopharmaceuticals (688513.SH): Nifedipine hydrochloride injection approved by the FDA in the USA for pharmaceutical registration.

Gelonghui Finance ·  Sep 9 06:27

Gelonghui, September 9丨Yuandong Biotech (688513.SH) announced that Chengdu Shuode Pharmaceutical Co., Ltd. (“Shuode Pharmaceutical”), a wholly-owned subsidiary of the company, recently received a notice from the US Food and Drug Administration (“US FDA”). Shuode Pharmaceutical's simplified new drug application (ANDA, or US generic drug application) for nicardipine hydrochloride injection declared to the US FDA has been officially approved. The main component of nicardipine hydrochloride injection is nicardipine hydrochloride. It is indicated for short-term treatment of hypertension when oral administration is not possible.

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