| 备案号 | Y国备2024000648 |
|---|---|
| 药品通用名称 | 枸橼酸西地那非 |
| 英文名称/拉丁名称 | Sildenafil Citrate |
| 药品批准文号/注册证书/原料药登记号 | 暂无权限 |
| 生产企业 | 暂无权限 |
| 生产企业（英文） | Apitoria Pharma Private Limited |
| 生产企业地址 | Unit-IV, Sy. No's. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No's. 1, 2, 4 to 9, 11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India, PIN: 532 409 |
| 上市许可持有人 | Apitoria Pharma Private Limited |
| 上市许可持有人（英文） | Apitoria Pharma Private Limited |
| 上市许可持有人地址 | Unit-IV, Sy. No's. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No's. 1, 2, 4 to 9, 11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India, PIN: 532 409 |
| 境外生产药品注册代理机构 | 安若维他药业泰州有限公司 |
| 境外生产药品注册代理机构地址 | 泰州市医药高新区祥泰路196号 |
| 备案内容 | 暂无权限 |
| 备案机关 | 国家药品监督管理局药品审评中心 |
| 备案日期 | 2024-04-02 |
| 备注 | 经审查，此次备案涉及原料药登记人实际变更，请登记人按照补充申请进行申报。 |
Apitoria Pharma Private Limited生产的枸橼酸西地那非（批号：Y20200001254）；
已于2024-04-02进行备案
枸橼酸西地那非
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