| 备案号 | Y国备2024000646 |
|---|---|
| 药品通用名称 | 盐酸帕罗西汀 |
| 英文名称/拉丁名称 | Paroxetine 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 I, Sy. Nos. 379, 385, 386, 388 to 396, Borpatla Village, Hathnoora Mandal, Sanga Reddy District, Telangana, India, Pin code 502296 |
| 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 I, Sy. Nos. 379, 385, 386, 388 to 396, Borpatla Village, Hathnoora Mandal, Sanga Reddy District, Telangana, India, Pin code 502296 |
| 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生产的盐酸帕罗西汀（批号：Y20200001156）；
已于2024-04-02进行备案
盐酸帕罗西汀
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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-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”。
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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’ 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”。
