Qingdao Baiyang Pharmaceutical Co., Ltd. Metformin Hydrochloride Sustained Release Tablets (Osmotic Pump Type) Received Marketing Approval from the US FDA

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Release Time：2019-01-11 Views：441

2018年12月27日，美国FDA正式批准我公司盐酸二甲双胍缓释片（渗透泵型）上市许可，ANDA号为：A209993。盐酸二甲双胍缓释片适用于单用饮食和运动治疗不能获得良好控制的 Ⅱ型糖尿病患者，尤其是肥胖和伴高胰岛素血症者，原研药为ANDRX LABS LLC公司的FORTAMET。盐酸二甲双胍缓释片获得美国FDA上市批准标志着青岛百洋制药有限公司在缓控释高端制剂产品研发、生产及质量体系等方面达到了国际先进水平，跨入制剂国际化的先进制药企业行列，对公司未来拓展美国市场及国内市场带来积极深远的影响。

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