| 专论编号 | 物质名称 | 证书持有人 | 持有人ORG-ID和LOC-ID | 证书编号 | 发布日期 | 证书状态 | 到期续期 | 证书结束日期 | 证书类型 | 上一程序的结束日期 | 历史数据 程序类型|结论|日期 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2631 | Rosuvastatin calcium | CADCHEM LABORATORIES LIMITED Chandigarh IN | 100039011;100083960 | CEP 2023-153 - Rev 00 | 2024/10/04 | Valid | 04/10/2029 | Chemical | |||
| 1060 | Zopiclone | Industriale Chimica S.R.L. Saronno IT | 100011692;100020331 | CEP 1997-075 - Rev 05 | 2024/10/04 | Valid | Chemical | 2024/10/04 | Minor revision|CEP granted|04/10/2024; Monograph revision|Accepted - CEP remains valid|17/05/2024 |
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| 14 | Calcium carbonate, Micronised 30 | MINERARIA SACILESE S.P.A. Sacile IT | 100049293;100083727 | CEP 2016-258 - Rev 01 | 2024/10/04 | Valid | Chemical | 2024/10/04 | Minor revision|CEP granted|04/10/2024; Renewal|CEP granted|06/10/2022 |
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| 1490 | Amisulpride, Process-2, Symed Labs Limited Unit-II, 2ASP | SYMED LABS LIMITED Hyderabad IN | 100018727;100053490 | CEP 2024-222 - Rev 00 | 2024/10/04 | Valid | 04/10/2029 | Chemical | 2024/10/04 | New application|CEP granted|04/10/2024 | |
| 1519 | Flurbiprofen | PHARMARON MANUFACTURING SERVICES (UK) LTD. Cramlington GB | 100004772;100006657 | CEP 2003-270 - Rev 05 | 2024/10/04 | Valid | Chemical | 2024/10/04 | Minor revision|CEP granted|04/10/2024; Minor revision|CEP granted|19/07/2023; Minor revision|Accepted - CEP remains valid|20/03/2023; Notification|CEP granted|22/02/2022; Monograph revision|CEP granted|16/12/2021; Minor revision|CEP granted|13/09/2021 |
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| 1698 | Melphalan | HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN | 100036821;100058182 | CEP 2023-324 - Rev 00 | 2024/10/04 | Valid | 04/10/2029 | Chemical | 2024/10/04 | New application|CEP granted|04/10/2024 | |
| 653 | Baclofen, Standard, milled, micronised | ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL | 100000470;100001572 | CEP 2010-316 - Rev 06 | 2024/10/04 | Valid | Chemical | 2024/10/04 | Notification|CEP granted|04/10/2024; Minor revision|CEP granted|27/08/2024; Minor revision|Accepted - CEP remains valid|30/05/2023; Administrative procedure|CEP granted|03/03/2021; Minor revision|CEP granted|18/02/2021 |
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| 2932 | Rivaroxaban | SYMED LABS LIMITED Hyderabad IN | 100018727;100053490 | CEP 2021-091 - Rev 01 | 2024/10/04 | Valid | 21/07/2028 | Chemical | 2023/07/21 | New application|CEP granted|21/07/2023 | |
| 2270 | Sildenafil citrate | TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN | 100004452;100001862 | CEP 2013-346 - Rev 02 | 2024/10/04 | Valid | Chemical | 2022/03/24 | Minor revision|CEP granted|24/03/2022; Renewal|CEP granted|04/08/2020 |
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| 766 | Flucytosine | MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN | 100013041;100021615 | CEP 2018-011 - Rev 04 | 2024/10/04 | Valid | 12/12/2024 | Chemical | 2024/01/19 | Minor revision|CEP granted|19/01/2024; Notification|CEP granted|15/02/2023; Minor revision|CEP granted|16/09/2020 |
|
| 1274 | Tylosin tartrate for veterinary use | ELANCO ANIMAL HEALTH INCORPORATED Greenfield US | 100012274;100020462 | CEP 2001-016 - Rev 04 | 2024/10/04 | Valid | Chemical | 2020/01/13 | |||
| 2191 | Atorvastatin calcium, Process 4, polymorphic form-I | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2024-238 - Rev 00 | 2024/10/04 | Valid | 04/10/2029 | Chemical | |||
| 2743 | Zoledronic acid monohydrate | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2021-269 - Rev 01 | 2024/10/04 | Valid | 24/07/2028 | Chemical | 2023/07/24 | New application|CEP granted|24/07/2023 | |
| 2778 | Sitagliptin phosphate monohydrate, Enzymatic method | RUYUAN HEC PHARM CO., LTD. Shaoguan CN | 100023129;100031882 | CEP 2024-352 - Rev 00 | 2024/10/03 | Valid | 03/10/2029 | Chemical | 2024/10/03 | New application|CEP granted|03/10/2024 | |
| 712 | Desmopressin | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2024-028 - Rev 00 | 2024/10/03 | Valid | 03/10/2029 | Chemical | 2024/10/03 | New application|CEP granted|03/10/2024 | |
| 2932 | Rivaroxaban, Micronised, Polymorphic Form-I | USV PRIVATE LIMITED Mumbai IN | 100006251;100010851 | CEP 2023-116 - Rev 01 | 2024/10/03 | Valid | 03/09/2029 | Chemical | 2024/10/03 | Minor revision|CEP granted|03/10/2024; New application|CEP granted|03/09/2024 |
|
| 1737 | Testosterone isocaproate | ASPEN OSS B.V. Oss NL | 100011619;100050602 | CEP 2023-084 - Rev 00 | 2024/10/03 | Valid | 03/10/2029 | Chemical | 2024/10/03 | New application|CEP granted|03/10/2024 | |
| 2191 | Atorvastatin calcium | ZHEJIANG HAISEN PHARMACEUTICAL CO., LTD. Xiangtan Village CN | 100024637;100033815 | CEP 2020-142 - Rev 02 | 2024/10/02 | Valid | 19/10/2027 | Chemical | 2024/10/03 | Notification|CEP granted|03/10/2024; Minor revision|CEP granted|07/11/2023; New application|CEP granted|19/10/2022 |
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| 1300 | Cefuroxime axetil, Amorphous | COVALENT LABORATORIES PRIVATE LIMITED Hyderabad IN | 100038841;100060982 | CEP 2011-172 - Rev 03 | 2024/10/02 | Valid | Chemical | 2024/10/03 | Minor revision|CEP granted|03/10/2024; Minor revision|Accepted - CEP remains valid|22/05/2023; Minor revision|Accepted - CEP remains valid|14/03/2023; Minor revision|CEP granted|09/03/2021 |
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| 2577 | Oxcarbazepine, Micronised and non-micronised | Hubei Gedian Humanwell Pharmaceutical Co., Ltd. Ezhou City CN | 100015482;100024200 | CEP 2018-165 - Rev 02 | 2024/10/02 | Valid | Chemical | 2024/10/03 | Renewal|CEP granted|03/10/2024; Minor revision|CEP granted|07/07/2023 |
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