Aurobindo Pharma获得FDA批准和头孢氨苄片的CGT指定,预计将在25财年第三季度推出。 Aurobindo Pharma receives FDA approval & CGT designation for Cephalexin Tablets, set to launch in Q3 FY25.
欧罗宾多制药公司获得FDA的最终批准,可以生产250 mg和500 mg剂量的Cefhalexin Tablet USP,这与Eli Lilly的Keflet药片具有生物等价性. Aurobindo Pharma has received final FDA approval to manufacture Cephalexin Tablets USP in 250 mg and 500 mg dosages, which are bioequivalent to Eli Lilly's Keflet Tablets. 公司还获得了竞争性通用疗法名称, 授予了180天的共享独家权. The company has also secured Competitive Generic Therapy designation, granting it 180 days of shared exclusivity. Aurobindo 现在持有 FDA 的 523 项 ANDA 批准,其中包括 506 项最终批准。 Aurobindo now holds 523 ANDA approvals from the FDA, including 506 final approvals. 预计该产品将在25财政年度第3季度发射。 The product is anticipated to launch in Q3 FY25.