| 备案号 | Y国备2024001143 |
|---|---|
| 药品通用名称 | 盐酸吡格列酮 |
| 英文名称/拉丁名称 | Pioglitazone 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 | 2024-06-04 |
| 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生产的盐酸吡格列酮（批号：Y20200000074）；
已于2024-06-04进行备案
盐酸吡格列酮
其他厂家
Y20170001510
批准日期:2025-09-02
国药准字H20174030/Y20190006771
批准日期:2024-12-21
Y20170001510
批准日期:2023-03-31
Y20190007352
批准日期:2022-11-23
国药准字H20040466/Y20190004634
批准日期:2021-08-30
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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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批准日期:2024-04-02
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”。
