| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |
| 42 | Magnesium carbonate, light | SCORA Caffiers FR | 100017757;100026517 | CEP 2024-058 - 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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| 412 | Sodium citrate dihydrate | JUNGBUNZLAUER LADENBURG GMBH Ladenburg DE | 100014785;100073136 | CEP 2018-273 - Rev 06 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Renewal|CEP granted|21/10/2024; Notification|CEP granted|21/06/2024; Notification|Accepted - CEP remains valid|24/08/2023; Minor revision|CEP granted|01/09/2022; Minor revision|CEP granted|09/06/2021; Minor revision|CEP granted|04/06/2020 |
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| 1520 | Foscarnet sodium hexahydrate | LIANYUNGANG RUNZHONG PHARMACEUTICAL CO., LTD. Lianyungang CN | 100019457;100028232 | CEP 2017-137 - Rev 01 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Notification|Accepted - CEP remains valid|24/06/2024; Renewal|CEP granted|27/07/2023; Minor revision|Accepted - CEP remains valid|08/03/2022; Notification|Accepted - CEP remains valid|11/01/2022; Minor revision|Accepted - CEP remains valid|23/11/2020 |
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| 2931 | Sorafenib tosilate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2021-247 - Rev 02 | 2025/07/11 | Valid | 10/07/2028 | Chemical | 2025/07/11 | Monograph revision|CEP granted|11/07/2025; Minor revision|CEP granted|23/04/2024; New application|CEP granted|10/07/2023 |
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| 883 | Calcitriol, Process 2 (F007V1) | FORMOSA LABORATORIES, INC. Taoyuan TW | 100011879;100018688 | CEP 2020-150 - Rev 03 | 2025/07/11 | Valid | 22/10/2026 | Chemical | 2025/07/11 | Notification|CEP granted|11/07/2025; Monograph revision|CEP granted|18/12/2024; Administrative procedure|CEP granted|18/11/2021; New application|CEP granted|22/10/2021 |
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| 1472 | Sodium hyaluronate, GS-200; intrinsic viscosity 2.77 m3/kg; from fermentation; for parenteral administration, including intra-ocular use | KIKKOMAN BIOCHEMIFA CO. Noda City JP | 100039417;100087689 | CEP 2020-138 - Rev 01 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Renewal|CEP granted|11/07/2025; Notification|Accepted - CEP remains valid|03/05/2024; New application|CEP granted|28/08/2020 |
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| 72 | Cholecalciferol, Site Sisseln | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 2019-351 - Rev 02 | 2025/07/11 | Valid | Chemical and TSE | 2025/11/26 | Notification|Accepted - CEP remains valid|26/11/2025; Notification|CEP granted|11/07/2025; Renewal|CEP granted|14/03/2025 |
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| 2777 | Pregabalin | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2020-024 - Rev 03 | 2025/07/11 | Valid | 03/02/2027 | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Minor revision|CEP granted|19/06/2024; Major revision|CEP granted|16/09/2022; New application|CEP granted|03/02/2022 |
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| 2631 | Rosuvastatin calcium | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL | 100002351;100005259 | CEP 2015-090 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Minor revision|Accepted - CEP remains valid|21/12/2023; Minor revision|Accepted - CEP remains valid|02/05/2023; Minor revision|CEP granted|20/04/2022; Minor revision|Rejected|02/03/2022; Renewal|CEP granted|01/07/2021; Monograph revision|Accepted - CEP remains valid|27/05/2020 |
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| 2759 | Benzydamine hydrochloride | BAL PHARMA LIMITED Bengaluru IN | 100016398;100041736 | CEP 2021-325 - Rev 02 | 2025/07/11 | Valid | 12/04/2029 | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; Administrative procedure|CEP granted|05/06/2024; New application|CEP granted|12/04/2024 |
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| 2594 | Duloxetine hydrochloride, Process-K | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-273 - Rev 01 | 2025/07/11 | Valid | 22/10/2029 | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025; New application|CEP granted|22/10/2024 |
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| 2288 | Citalopram hydrobromide | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2009-012 - Rev 02 | 2025/07/11 | Valid | Chemical | 2025/07/11 | Minor revision|CEP granted|11/07/2025 |
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