替格瑞洛备案及生产企业信息

1.有效期由18个月延长至60个月；2.公司名称由“ZCL CHEMICALS LIMITED”变为“Cohance Lifesciences Limited”；3.生产地址描述性变更，由“Plot No. 3102/B, GIDC Estate, Ankleshwar-393 002, Dist: Bharuch, Gujarat (India)”变为“API Unit - III, PLOT NO. - 3102 /B, GIDC, ANKLESHWAR - 393 002, DIST - BHARUCH, GUJARAT, INDIA”；4.变更包装标签上的logo。

生产企业名称和地址由“ZCL Chemicals Limited”“Plot No. 3102/B, GIDC Estate, Ankleshwar-393002, Dist: Bharuch, Gujarat （India）”变更为“COHANCE LIFESCIENCES LIMITED”“API UNIT - III, PLOT NO. - 3102 /B, GIDC, ANKLESHWAR - 393002, DIST – BHARUCH, GUJARAT, INDIA”

1.延长原料药有效期至36个月。 2.本品原料药申请人、生产厂、生产地址的名称与表述发生变更，申请人和生产厂由“ZCL Chemicals Limited“变更为“COHANCE LIFESCIENCES LIMITED”；生产地址由“Plot No. 3102/B, GIDC Estate,Ankleshwar-393 002, Dist: Bharuch , Gujarat (India)”变更为“API UNIT - III, PLOT NO. - 3102/B, GIDC, ANKLESHWAR - 393 002, DIST - BHARUCH, GUJARAT, INDIA”，本次变更仅为文字性变更。

变更生产商名称和地址

将阿立哌唑上市申请批准通知书中载明的“原料药申请人”名称和“生产企业”名称从“ZCL CHEMICALS LIMITED”修改为“COHANCE LIFESCIENCES LIMITED”。实际生产地址虽然未发生变化，但为了和CoPP保持一致，修改为“API UNIT - III, PLOT NO. - 3102/B, GIDC, ANKLESHWAR - 393 002, DIST - BHARUCH, GUJARAT, INDIA”。