| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 474 | Chlordiazepoxide hydrochloride, Process 2 | F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT | 100011866;100022277 | CEP 2014-087 - Rev 02 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; Minor revision|CEP granted|05/04/2023 |
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| 3087 | Ticagrelor | JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN | 100020812;100080065 | CEP 2021-303 - Rev 01 | 2025/09/12 | Valid | 08/08/2028 | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; New application|CEP granted|08/08/2023 |
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| 2191 | Atorvastatin calcium, Process-IV | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2021-079 - Rev 03 | 2025/09/12 | Valid | 05/07/2026 | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; Minor revision|CEP granted|29/08/2024; Monograph revision|CEP granted|01/08/2022; New application|CEP granted|05/07/2021 |
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| 2230 | Latanoprost | C-SQUARED PHARMA LIMITED Cork IE | 100045238;100077698 | CEP 2024-091 - Rev 00 | 2025/09/12 | Valid | 12/09/2030 | Chemical | 2025/09/12 | New application|CEP granted|12/09/2025 | |
| 1838 | Mint oil, partly dementholised, Rectified | FREY + LAU GMBH Henstedt-Ulzburg DE | 100017333;100026131 | CEP 2019-229 - Rev 01 | 2025/09/11 | Valid | Herbal | 2025/09/11 | Renewal|CEP granted|11/09/2025; Notification|Accepted - CEP remains valid|13/08/2021; Notification|Accepted - CEP remains valid|11/12/2020 |
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| 2918 | Everolimus, 2.0% BHT | FARMHISPANIA S.A. Montmeló ES | 100011645;100022190 | CEP 2019-256 - Rev 03 | 2025/09/11 | Valid | Chemical | 2025/09/11 | Renewal|CEP granted|11/09/2025; Major revision|CEP granted|27/04/2023; Minor revision|CEP granted|24/02/2022 |
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| 2765 | Eplerenone, Form-L | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2019-263 - Rev 03 | 2025/09/11 | Valid | 06/04/2026 | Chemical | 2025/09/11 | Minor revision|CEP granted|11/09/2025; Major revision|CEP granted|05/03/2024; Minor revision|CEP granted|17/11/2021 |
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| 2191 | Atorvastatin calcium, Form I, ATN process | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2020-092 - Rev 03 | 2025/09/11 | Valid | Chemical | 2025/09/11 | Renewal|CEP granted|11/09/2025; Minor revision|Accepted - CEP remains valid|13/08/2024; Minor revision|CEP granted|02/06/2023; Monograph revision|CEP granted|05/10/2022; New application|CEP granted|01/10/2020 |
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| 2617 | Aripiprazole, Micronised | SYNTHON B.V. Nijmegen NL | 100001342;100005475 | CEP 2019-191 - Rev 02 | 2025/09/11 | Valid | Chemical | 2025/09/11 | Minor revision|CEP granted|11/09/2025; Renewal|CEP granted|07/07/2025; Minor revision|Accepted - CEP remains valid|11/09/2024; Minor revision|Accepted - CEP remains valid|29/07/2024; Notification|Rejected|10/06/2024; Minor revision|Accepted - CEP remains valid|21/11/2023; Minor revision|Accepted - CEP remains valid|16/06/2022; Monograph revision|Accepted - CEP remains valid|21/09/2021 |
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| 2736 | Imatinib mesilate, Process II | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | CEP 2020-086 - Rev 02 | 2025/09/11 | Valid | Chemical | 2025/09/11 | Renewal|CEP granted|11/09/2025; Minor revision|Accepted - CEP remains valid|12/09/2024; Major revision|CEP granted|03/02/2023; New application|CEP granted|09/12/2020 |
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| 1838 | Mint oil, partly dementholised, Double rectified | FREY + LAU GMBH Henstedt-Ulzburg DE | 100017333;100026131 | CEP 2019-234 - Rev 01 | 2025/09/11 | Valid | Herbal | 2025/09/11 | Renewal|CEP granted|11/09/2025; Notification|Accepted - CEP remains valid|13/08/2021; Notification|Accepted - CEP remains valid|14/12/2020 |
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| 2931 | Sorafenib tosilate, Form-III | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2021-430 - Rev 02 | 2025/09/11 | Valid | 31/08/2028 | Chemical | 2025/09/11 | Minor revision|CEP granted|11/09/2025; Monograph revision|Accepted - CEP remains valid|18/06/2025; Administrative procedure|CEP granted|15/09/2023; New application|CEP granted|01/09/2023 |
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| 1286 | Alfacalcidol | NANJING HERON PHARMACEUTICAL Co., Ltd. Nanjing CN | 100050591;100088354 | CEP 2024-060 - Rev 01 | 2025/09/11 | Valid | 19/12/2029 | Chemical and TSE | 2025/09/11 | Minor revision|CEP granted|11/09/2025; New application|CEP granted|20/12/2024 |
|
| 2591 | Celecoxib | ZHEJIANG CHEMSYN PHARM. CO., LTD. Quzhou CN | 100025798;100035044 | CEP 2020-170 - Rev 01 | 2025/09/11 | Valid | Chemical | 2025/09/11 | Renewal|CEP granted|11/09/2025; New application|CEP granted|13/01/2021 |
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| 693 | Tretinoin | CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO., LTD. Chongqing CN | 100024073;100088372 | CEP 2020-183 - Rev 01 | 2025/09/11 | Valid | 05/09/2027 | Chemical | 2025/09/11 | Minor revision|CEP granted|11/09/2025; New application|CEP granted|05/09/2022 |
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| 2970 | Almotriptan malate, Crystalline form, micronised and non-micronised | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | CEP 2020-253 - Rev 01 | 2025/09/11 | Valid | 25/01/2027 | Chemical | 2025/09/11 | Minor revision|CEP granted|11/09/2025; Notification|Rejected|11/07/2025; New application|CEP granted|25/01/2022 |
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| 2541 | Quetiapine Fumarate, Micronised and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2022-280 - Rev 02 | 2025/09/11 | Valid | 18/03/2029 | Chemical | 2025/09/11 | Minor revision|CEP granted|11/09/2025; Notification|Accepted - CEP remains valid|24/09/2024; Administrative procedure|CEP granted|04/04/2024; New application|CEP granted|18/03/2024 |
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| 1290 | Amikacin sulfate | ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua City CN | 100024897;100034088 | CEP 2023-430 - Rev 01 | 2025/09/11 | Valid | 11/07/2030 | Chemical | 2025/09/11 | Minor revision|CEP granted|11/09/2025; New application|CEP granted|11/07/2025 |
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| 496 | Glycerol | KLK EMMERICH GMBH Duesseldorf DE | 100048726;100080794 | CEP 2024-019 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/12/17 | Minor revision|Accepted - CEP remains valid|17/12/2025; New application|CEP granted|10/09/2025 |
|
| 2110 | Isradipine, Micronised, non-micronised | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2024-072 - Rev 00 | 2025/09/10 | Valid | 10/09/2030 | Chemical | 2025/09/10 | New application|CEP granted|10/09/2025 |
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