| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1765 | Salmeterol xinafoate, Micronised | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2018-168 - Rev 01 | 2025/07/15 | Valid | Chemical | 2025/07/15 | Renewal|CEP granted|15/07/2025 | ||
| 576 | Allopurinol | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1998-118 - Rev 08 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Notification|CEP granted|20/12/2021; Minor revision|Accepted - CEP remains valid|15/03/2021 |
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| 1028 | Metoprolol tartrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2001-240 - Rev 04 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|22/09/2023; Notification|CEP granted|04/02/2022 |
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| 253 | Ascorbic acid | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 1996-078 - Rev 06 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Monograph revision|Accepted - CEP remains valid|13/07/2023; Minor revision|CEP granted|04/10/2022 |
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| 1651 | Clarithromycin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2004-114 - Rev 05 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|19/03/2024; Notification|CEP granted|05/01/2022; Notification|Accepted - CEP remains valid|19/10/2021 |
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| 807 | Ascorbyl palmitate | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2002-255 - Rev 01 | 2025/07/11 | Withdrawn by Holder | 2025/09/02 | Chemical | 2025/07/11 | ||
| 1073 | Biotin | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2001-405 - Rev 07 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|CEP granted|22/04/2024; Minor revision|CEP granted|16/01/2023; Minor revision|CEP granted|02/02/2022 |
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| 1706 | Thiamazole | CU Chemie Uetikon GmbH Lahr DE | 100012598;100021471 | CEP 2008-293 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Monograph revision|CEP granted|11/07/2025; Minor revision|CEP granted|04/12/2023 |
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| 2296 | Pantoprazole sodium sesquihydrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2009-302 - Rev 04 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|10/07/2024; Notification|CEP granted|21/12/2021; Minor revision|CEP granted|08/06/2021 |
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| 2219 | Lansoprazole | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2009-301 - Rev 05 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|CEP granted|05/04/2024; Notification|CEP granted|10/03/2022; Notification|CEP granted|20/12/2021; Minor revision|Accepted - CEP remains valid|11/12/2020 |
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| 2404 | Drospirenone | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-014 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|20/08/2024; Minor revision|Accepted - CEP remains valid|16/11/2023; Minor revision|Accepted - CEP remains valid|13/02/2023; Notification|CEP granted|04/01/2022 |
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| 470 | Calcium Pantothenate | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2004-267 - Rev 03 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|21/07/2021; Monograph revision|Accepted - CEP remains valid|16/04/2021 |
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| 2011 | Calcipotriol | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2007-223 - Rev 04 | 2025/07/11 | Valid | Chemical | 2025/10/31 | Notification|Accepted - CEP remains valid|31/10/2025; Notification|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|21/02/2023; Notification|Accepted - CEP remains valid|28/01/2022; Notification|CEP granted|04/01/2022; Minor revision|CEP granted|06/01/2021 |
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| 2191 | Atorvastatin calcium, Trihydrate Form-I, ATO3 Process | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2025-113 - Rev 00 | 2025/07/11 | Valid | 11/07/2030 | Chemical | 2025/07/11 | New application|CEP granted|11/07/2025 | |
| 2362 | Rifaximin, α-Form | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-415 - Rev 00 | 2025/07/11 | Valid | 11/07/2030 | Chemical | 2025/07/11 | New application|CEP granted|11/07/2025 | |
| 549 | Dexamethasone sodium phosphate | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2023-448 - Rev 00 | 2025/07/11 | Valid | 11/07/2030 | Chemical | 2025/07/11 | New application|CEP granted|11/07/2025 | |
| 2600 | Olmesartan medoxomil | CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100053345;100094249 | CEP 2018-232 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Renewal|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|20/09/2022; Major revision|CEP granted|08/07/2021; Minor revision|Rejected|22/02/2021 |
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| 2071 | Milk thistle dry extract, refined and standardised, DER: 20-35:1 | NINGBO GREEN-HEALTH PHARMACEUTICAL CO. LTD. Ningbo CN | 100021397;100030235 | CEP 2012-275 - Rev 02 | 2025/07/11 | Valid | Herbal | 2025/07/11 | Major revision|CEP granted|11/07/2025; Minor revision|Rejected|07/03/2025; Minor revision|Accepted - CEP remains valid|18/02/2025; Monograph revision|CEP granted|19/06/2024 |
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| 2763 | Cisatracurium besilate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2016-093 - Rev 01 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|04/07/2024; Notification|Accepted - CEP remains valid|13/04/2023; Renewal|CEP granted|16/05/2022; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|29/05/2020 |
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| 2631 | Rosuvastatin calcium, Process G 2410 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2017-018 - Rev 01 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Renewal|CEP granted|20/05/2022; Notification|CEP granted|22/11/2021; Minor revision|CEP granted|09/07/2021; Monograph revision|Accepted - CEP remains valid|02/10/2020 |
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