| 备案号 | Y国备2024000649 |
|---|---|
| 药品通用名称 | 盐酸舍曲林 |
| 英文名称/拉丁名称 | Sertraline Hydrochloride |
| 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生产的盐酸舍曲林（批号：Y20200000786）；
已于2024-04-02进行备案
盐酸舍曲林
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1.本品原料药申请人和生产企业的名称和地址表述发生变更，由“Aurobindo Pharma Limited,(Unit-XI), 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 -532 409”变更为“Apitoria Pharma Private Limited,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”。
2.对盐酸吡格列酮《化学原料药上市申请批准通知书》附件（生产工艺信息表）中明显笔误内容进行勘误。
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本品原料药申请人和生产企业的名称和地址发生变更，实际的生产地址不变。原料药申请人的名称及地址由“Aurobindo Pharma Limited, Plot No.2, Maitrivihar, Ameerpet, Hyderabad Telangana, INDIA”变更为“Apitoria Pharma Private Limited, Galaxy, Floors: 22-24, Plot No.1, Survey No. 83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad - 500 032, Telangana, India”；生产企业的名称及地址由“Aurobindo Pharma Limited, Unit-XI, 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 -532 409”变更为“Apitoria Pharma Private Limited, 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”。
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本品原料药申请人和生产企业的名称和地址表述发生变更，由“Aurobindo Pharma Limited, Unit-I, Sy. No. 379, 385, 386, 388 to 396, Borpatla (Village), Hatnoora (Mandal), Sanga Reddy (District), Telangana, INDIA”变更为“Apitoria Pharma Private Limited, Unit I, Sy. Nos. 379, 385, 386, 388 to 396, Borpatla Village, Hathnoora Mandal, Sanga Reddy District, Telangana, India, Pin code 502296”。
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本品原料药申请人和生产企业的名称和地址表述发生变更，由“Aurobindo Pharma Limited, Unit-XI, Sy. No. 1/22, 2/1 to 5, 6 to 18, 61 to 69, Pydibhimavaram (Village), Ranasthalam (Mandal), Srikakulam (District), Andhra Pradesh (State), INDIA”变更为“Apitoria Pharma Private Limited, 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”。
