盐酸缬更昔洛韦备案及生产企业信息

制药厂商对可能存在的多种具有警示结构的潜在致突变杂质进行补充研究。

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。

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”。

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”。

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”。