| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2574 | Entacapone, 1313 | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2021-051 - Rev 01 | 2026/01/22 | Valid | 21/10/2026 | Chemical | 2026/01/22 | Minor revision|CEP granted|22/01/2026; Notification|Rejected|12/09/2022; New application|CEP granted|21/10/2021 |
|
| 203 | Polymyxin B sulfate | XELLIA PHARMACEUTICALS APS Copenhagen S DK | 100004144;100002734 | CEP 1998-061 - Rev 06 | 2026/01/22 | Valid | Chemical | 2026/01/22 | Minor revision|CEP granted|22/01/2026; Notification|Accepted - CEP remains valid|28/06/2022; Minor revision|Accepted - CEP remains valid|20/12/2021 |
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| 2119 | Venlafaxine hydrochloride, Form B | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2009-270 - Rev 08 | 2026/01/22 | Valid | Chemical | 2026/01/22 | Minor revision|CEP granted|22/01/2026; Minor revision|Accepted - CEP remains valid|27/08/2025; Minor revision|Accepted - CEP remains valid|06/09/2024; Notification|CEP granted|27/01/2023; Notification|Accepted - CEP remains valid|07/10/2021; Minor revision|Accepted - CEP remains valid|12/02/2021 |
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| 2933 | Deferasirox | MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN | 100023732;100032901 | CEP 2025-040 - Rev 00 | 2026/01/22 | Valid | 22/01/2031 | Chemical | 2026/01/22 | New application|CEP granted|22/01/2026 | |
| 2131 | Tamsulosin hydrochloride | ASTELLAS PHARMA INC. Tokyo JP | 100004276;100008205 | CEP 2007-253 - Rev 06 | 2026/01/22 | Valid | Chemical | 2026/01/22 | Notification|CEP granted|22/01/2026; Notification|CEP granted|24/10/2024; Notification|CEP granted|11/05/2022; Minor revision|CEP granted|07/06/2021 |
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| 2743 | Zoledronic acid monohydrate | SCINOPHARM TAIWAN LTD. Shanhua TW | 100012108;100019515 | CEP 2019-281 - Rev 02 | 2026/01/22 | Valid | Chemical | 2026/01/22 | Renewal|CEP granted|22/01/2026; Notification|CEP granted|16/10/2024 |
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| 767 | Fludrocortisone acetate, Micronised | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2019-084 - Rev 02 | 2026/01/21 | Valid | Chemical | 2026/04/14 | Minor revision|Rejected|14/04/2026; Renewal|CEP granted|21/01/2026; Monograph revision|CEP granted|01/04/2025 |
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| 2574 | Entacapone, Form-A, micronised, non-micronised | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2011-191 - Rev 05 | 2026/01/21 | Valid | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Notification|CEP granted|24/03/2023; Minor revision|CEP granted|28/09/2022; Notification|CEP granted|10/12/2021; Minor revision|Accepted - CEP remains valid|27/08/2021; Notification|Accepted - CEP remains valid|14/10/2020 |
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| 1208 | Fenbendazole for veterinary use, Process 2 | SHAANXI HANJIANG PHARMACEUTICAL GROUP CO., LTD. Hanzhong CN | 100012369;100079669 | CEP 2018-250 - Rev 03 | 2026/01/21 | Valid | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Renewal|CEP granted|22/04/2024; Minor revision|CEP granted|28/11/2022 |
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| 2896 | Thiocolchicoside crystallised from ethanol | INDIA GLYCOLS LIMITED Dehradun IN | 100038944;100061244 | CEP 2020-066 - Rev 02 | 2026/01/21 | Valid | 06/04/2027 | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Major revision|CEP granted|05/01/2024; New application|CEP granted|06/04/2022 |
|
| 1444 | Macrogols, Type 3350 and 4000 | SASOL GERMANY GMBH Marl DE | 100043602;100072176 | CEP 2009-392 - Rev 02 | 2026/01/21 | Valid | Chemical | 2026/01/21 | Notification|CEP granted|21/01/2026; Major revision|CEP granted|06/07/2022 |
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| 2234 | Meropenem trihydrate, Synthetic origin, Sterile, Process II | SHENZHEN HAIBIN PHARMACEUTICAL CO., LTD. Shenzhen City CN | 100021561;100030252 | CEP 2024-097 - Rev 02 | 2026/01/21 | Valid | 11/06/2030 | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Administrative procedure|CEP granted|19/08/2025; New application|CEP granted|11/06/2025 |
|
| 2409 | Diacerein | RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN | 100039283;100061839 | CEP 2024-436 - Rev 00 | 2026/01/21 | Valid | 21/01/2031 | Chemical | 2026/01/21 | New application|CEP granted|21/01/2026 | |
| 2019 | Perindopril tert-butylamine, Crystalline form-α | MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN | 100014794;100023345 | CEP 2025-249 - Rev 00 | 2026/01/21 | Valid | 21/01/2031 | Chemical | 2026/01/21 | New application|CEP granted|21/01/2026 | |
| 45 | Methyldopa, Site Yongtai Chiral, Process A | ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO. LTD. Taizhou CN | 100041319;100068021 | CEP 2025-526 - Rev 00 | 2026/01/21 | Valid | 21/01/2031 | Chemical | 2026/01/21 | New application|CEP granted|21/01/2026 | |
| 2637 | Pemetrexed disodium heptahydrate | JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN | 100034195;100092374 | CEP 2022-265 - Rev 01 | 2026/01/21 | Valid | 19/06/2028 | Chemical | 2026/01/21 | Minor revision|CEP granted|21/01/2026; Minor revision|Accepted - CEP remains valid|02/10/2024; New application|CEP granted|19/06/2023 |
|
| 1575 | Tiapride hydrochloride | ICROM S.R.L. Concorezzo IT | 100022464;100031145 | CEP 2023-003 - Rev 01 | 2026/01/20 | Valid | 19/01/2029 | Chemical | 2026/01/20 | Minor revision|CEP granted|20/01/2026; New application|CEP granted|19/01/2024 |
|
| 2896 | Thiocolchicoside crystallised from ethanol | QUAD LIFESCIENCES PRIVATE LIMITED S.A.S Nagar IN | 100050170;100087590 | CEP 2023-103 - Rev 00 | 2026/01/20 | Valid | 20/01/2031 | Chemical | 2026/01/20 | New application|CEP granted|20/01/2026 | |
| 2617 | Aripiprazole | ALKEM LABORATORIES LIMITED Mumbai IN | 100005554;100010367 | CEP 2024-180 - Rev 00 | 2026/01/20 | Valid | 20/01/2031 | Chemical | 2026/01/20 | New application|CEP granted|20/01/2026 | |
| 198 | Oxytetracycline hydrochloride | HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang CN | 100016575;100025368 | CEP 2021-099 - Rev 02 | 2026/01/20 | Valid | 16/06/2027 | Chemical | 2026/01/20 | Minor revision|CEP granted|20/01/2026; Monograph revision|Accepted - CEP remains valid|23/12/2024; Minor revision|Accepted - CEP remains valid|07/09/2023; Administrative procedure|CEP granted|28/06/2022; New application|CEP granted|20/06/2022 |
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