| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2244 | Tacrolimus monohydrate, Process II | CONCORD BIOTECH LIMITED Ahmedabad IN | 100005519;100000897 | CEP 2020-227 - Rev 02 | 2025/07/29 | Valid | Chemical | 2025/07/29 | Renewal|CEP granted|29/07/2025; Major revision|CEP granted|19/12/2022; New application|CEP granted|26/11/2020 |
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| 3139 | Brivaracetam, Micronised and Non-micronised | MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN | 100013041;100021615 | CEP 2024-061 - Rev 01 | 2025/07/29 | Valid | 12/08/2029 | Chemical | 2025/07/29 | Minor revision|CEP granted|29/07/2025; New application|CEP granted|12/08/2024 |
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| 1058 | Vancomycin hydrochloride, Lyophilized | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2020-058 - Rev 04 | 2025/07/28 | Valid | Chemical | 2025/07/28 | Renewal|CEP granted|28/07/2025; Monograph revision|CEP granted|28/10/2024; Minor revision|CEP granted|25/05/2023; Minor revision|CEP granted|21/01/2022; New application|CEP granted|22/07/2020 |
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| 2751 | Valaciclovir hydrochloride hydrate | FLAMMA S.P.A. Chignolo d'Isola IT | 100012051;100020885 | CEP 2018-073 - Rev 04 | 2025/07/28 | Valid | Chemical | 2025/07/28 | Transfer of holdership|CEP granted|28/07/2025; Renewal|CEP granted|21/01/2025; Minor revision|Accepted - CEP remains valid|24/04/2023; Minor revision|CEP granted|30/05/2022; Notification|CEP granted|22/11/2021; Minor revision|Accepted - CEP remains valid|04/05/2021 |
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| 714 | Doxorubicin Hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2003-111 - Rev 07 | 2025/07/28 | Valid | Chemical | 2025/12/03 | Minor revision|Accepted - CEP remains valid|03/12/2025; Notification|CEP granted|28/07/2025; Minor revision|CEP granted|29/05/2024; Notification|Accepted - CEP remains valid|23/01/2023; Notification|CEP granted|20/12/2021; Minor revision|Accepted - CEP remains valid|27/05/2021 |
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| 1559 | Risperidone | ICROM S.R.L. Concorezzo IT | 100022464;100031145 | CEP 2023-293 - Rev 00 | 2025/07/28 | Valid | 28/07/2030 | Chemical | 2025/07/28 | New application|CEP granted|28/07/2025 | |
| 1524 | Gliclazide | ANUH PHARMA LTD. Mumbai IN | 100021566;100030259 | CEP 2021-398 - Rev 02 | 2025/07/28 | Valid | 11/08/2028 | Chemical | 2025/07/28 | Minor revision|CEP granted|28/07/2025; Minor revision|CEP granted|20/12/2023; New application|CEP granted|11/08/2023 |
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| 1491 | Amlodipine besilate, TY 45 | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2025-166 - Rev 00 | 2025/07/28 | Valid | 28/07/2030 | Chemical | 2025/07/28 | New application|CEP granted|28/07/2025 | |
| 1653 | Potassium clavulanate, diluted, with microcrystalline Cellulose in the ratio 7:3 | FERMIC, S.A. DE C.V. Mexico City MX | 100017232;100026028 | CEP 2009-358 - Rev 01 | 2025/07/28 | Valid | Chemical | 2025/07/28 | Notification|CEP granted|28/07/2025 | ||
| 574 | Cholecalciferol concentrate (powder form), 100 000 IU/g, with all-rac-α-tocopherol | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2019-003 - Rev 01 | 2025/07/28 | Valid | Chemical and TSE | 2025/07/28 | Renewal|CEP granted|28/07/2025; Minor revision|Accepted - CEP remains valid|30/11/2023 |
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| 333 | Heparin sodium | SHENZHEN HEPALINK PHARMACEUTICAL GROUP CO., LTD. Shenzhen City CN | 100012154;100018639 | CEP 2006-059 - Rev 20 | 2025/07/28 | Valid | Chemical | 2025/07/28 | Major revision|CEP granted|28/07/2025; Minor revision|CEP granted|27/08/2024; Monograph revision|CEP granted|14/05/2024; Administrative procedure|CEP granted|04/10/2023; Major revision|CEP granted|26/09/2023; Minor revision|CEP granted|21/02/2023; Major revision|CEP granted|31/03/2021; Minor revision|CEP granted|28/10/2020; Minor revision|CEP granted|21/04/2020 |
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| 319 | Colistimethate sodium | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2018-085 - Rev 06 | 2025/07/28 | Valid | Chemical | 2025/07/28 | Minor revision|CEP granted|28/07/2025; Renewal|CEP granted|15/01/2025; Monograph revision|Accepted - CEP remains valid|24/03/2023; Administrative procedure|CEP granted|06/12/2022; Minor revision|CEP granted|28/11/2022; Minor revision|CEP granted|11/01/2022; Administrative procedure|CEP granted|05/05/2020 |
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| 2992 | Lacosamide, Crystalline form-1 | MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN | 100014794;100023345 | CEP 2018-060 - Rev 05 | 2025/07/28 | Valid | Chemical | 2025/07/28 | Minor revision|CEP granted|28/07/2025; Renewal|CEP granted|19/07/2024; Notification|CEP granted|25/10/2023; Minor revision|CEP granted|14/02/2023; Minor revision|Accepted - CEP remains valid|02/02/2022; Minor revision|CEP granted|25/09/2020 |
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| 2930 | Valganciclovir hydrochloride, Crystalline form | MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN | 100013041;100021615 | CEP 2023-285 - Rev 00 | 2025/07/28 | Valid | 28/07/2030 | Chemical | 2025/07/28 | New application|CEP granted|28/07/2025 | |
| 2887 | Raltegravir potassium, Form III | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2023-193 - Rev 00 | 2025/07/28 | Valid | 28/07/2030 | Chemical | 2025/07/28 | New application|CEP granted|28/07/2025 | |
| 40 | Magnesium oxide, light | SCORA Caffiers FR | 100017757;100026517 | CEP 2024-141 - Rev 00 | 2025/07/28 | Valid | 28/07/2030 | Chemical | 2025/07/28 | New application|CEP granted|28/07/2025 | |
| . | Newborn Bovine Calf Serum | GLOBAL LIFE SCIENCES SOLUTIONS NEW ZEALAND Tauranga NZ | 100052523;100092494 | CEP 2001-190 - Rev 07 | 2025/07/25 | Valid | TSE | 2025/07/25 | Notification|CEP granted|25/07/2025; Major revision|CEP granted|28/03/2023; Major revision|CEP granted|22/02/2023; Notification|Accepted - CEP remains valid|03/03/2022; Notification|CEP granted|05/06/2020 |
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| 1339 | Levocarnitine | NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN | 100021339;100054155 | CEP 2022-068 - Rev 01 | 2025/07/25 | Valid | 19/01/2029 | Chemical | 2025/07/25 | Minor revision|CEP granted|25/07/2025; New application|CEP granted|19/01/2024 |
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| 1314 | Dosulepin hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2003-157 - Rev 06 | 2025/07/25 | Valid | Chemical | 2025/07/25 | Minor revision|CEP granted|25/07/2025; Minor revision|CEP granted|10/08/2023 |
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| 2362 | Rifaximin, Alpha Form | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2019-125 - Rev 04 | 2025/07/25 | Valid | Chemical | 2025/07/25 | Renewal|CEP granted|25/07/2025; Minor revision|Accepted - CEP remains valid|06/09/2024; Minor revision|Accepted - CEP remains valid|05/02/2024; Administrative procedure|CEP granted|05/07/2021; Minor revision|CEP granted|21/06/2021; Minor revision|CEP granted|18/12/2020 |
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