| 备案号 | Y国备2024002960 |
|---|---|
| 药品通用名称 | 塞来昔布 |
| 英文名称/拉丁名称 | Celecoxib |
| 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 | 阿乐滨度（上海）贸易有限公司 |
| 境外生产药品注册代理机构地址 | 上海市长宁区仙霞路319号1401室 |
| 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 | 2025-01-03 |
| 备注 | 已备案 |
APITORIA PHARMA PRIVATE LIMITED生产的塞来昔布（批号：Y20170001012）；
已于2025-01-03进行备案
塞来昔布
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