| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2114 | Lysine acetate | EVONIK REXIM S.A.S. Ham FR | 100012329;100020964 | CEP 2010-155 - Rev 04 | 2025/04/02 | Valid | Chemical | 2025/04/02 | Notification|CEP granted|02/04/2025; Monograph revision|CEP granted|24/01/2024; Notification|CEP granted|14/03/2022 |
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| 1611 | Diosmin, Non-micronised, micronised | CHENGDU RUNDE PHARMACEUTICAL CO. LTD. Chengdu CN | 100024824;100095430 | CEP 2012-180 - Rev 03 | 2025/04/02 | Valid | Chemical | 2025/04/02 | Notification|CEP granted|02/04/2025; Minor revision|Accepted - CEP remains valid|20/02/2025; Minor revision|Accepted - CEP remains valid|11/07/2023; Minor revision|Accepted - CEP remains valid|01/02/2022; Minor revision|CEP granted|07/06/2021; Minor revision|CEP granted|12/06/2020 |
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| 1357 | Pheniramine maleate | SUPRIYA LIFESCIENCE LIMITED Mumbai IN | 100015796;100024574 | CEP 2015-030 - Rev 01 | 2025/04/02 | Valid | Chemical | 2025/04/02 | Major revision|CEP granted|02/04/2025; Minor revision|Rejected|05/09/2024; Renewal|CEP granted|18/03/2022 |
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| 1173 | Benserazide hydrochloride | COHANCE LIFESCIENCES LIMITED Hyderabad IN | 100011755;100021186 | CEP 2023-115 - Rev 00 | 2025/04/02 | Valid | 02/04/2030 | Chemical | 2025/04/02 | New application|CEP granted|02/04/2025 | |
| 633 | Pilocarpine hydrochloride | ZHEJIANG AUSUN PHARMACEUTICAL CO., LTD. Taizhou CN | 100014719;100023221 | CEP 2023-367 - Rev 00 | 2025/04/02 | Valid | 02/04/2030 | Chemical | 2025/04/02 | New application|CEP granted|02/04/2025 | |
| 2779 | Solifenacin succinate | SMS PHARMACEUTICALS LIMITED Hyderabad IN | 100011780;100061058 | CEP 2023-388 - Rev 00 | 2025/04/01 | Valid | 01/04/2030 | Chemical | 2025/04/01 | New application|CEP granted|01/04/2025 | |
| 576 | Allopurinol | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-007 - Rev 08 | 2025/04/01 | Valid | Chemical | 2025/04/01 | Minor revision|CEP granted|01/04/2025; Major revision|CEP granted|21/07/2023; Minor revision|CEP granted|30/03/2022; Minor revision|Accepted - CEP remains valid|18/11/2020 |
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| 2888 | Rupatadine fumarate | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2018-180 - Rev 03 | 2025/04/01 | Valid | Chemical | 2025/04/01 | Renewal|CEP granted|01/04/2025; Notification|CEP granted|02/02/2023; Minor revision|CEP granted|12/09/2022 |
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| 2373 | Meloxicam, Process-II | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2025-010 - Rev 00 | 2025/04/01 | Valid | 01/04/2030 | Chemical | 2025/04/01 | New application|CEP granted|01/04/2025 | |
| 1705 | Sertraline hydrochloride, Polymorphic Form-I, Process-2, Viyash Life Sciences Private Limited Unit-II, SLH | VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100040217;100065484 | CEP 2024-498 - Rev 00 | 2025/04/01 | Valid | 01/04/2030 | Chemical | 2025/04/01 | New application|CEP granted|01/04/2025 | |
| 253 | Ascorbic acid | Ningxia Qiyuan Pharmaceutical Co., Ltd. Yinchuan CN | 100019114;100027878 | CEP 2018-181 - Rev 02 | 2025/03/28 | Valid | Chemical | 2025/03/28 | Renewal|CEP granted|28/03/2025; Notification|Accepted - CEP remains valid|06/01/2025; Monograph revision|Accepted - CEP remains valid|13/07/2023; Minor revision|CEP granted|22/06/2022 |
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| 803 | Amiodarone hydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2003-072 - Rev 06 | 2025/03/28 | Valid | Chemical | 2025/03/28 | Monograph revision|CEP granted|28/03/2025; Notification|CEP granted|15/06/2021; Minor revision|Accepted - CEP remains valid|13/02/2020 |
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| 786 | Riboflavin sodium phosphate hydrate | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2010-254 - Rev 03 | 2025/03/28 | Valid | Chemical | 2025/09/22 | Minor revision|Accepted - CEP remains valid|22/09/2025; Administrative procedure|CEP granted|28/03/2025; Monograph revision|CEP granted|24/03/2025; Notification|CEP granted|04/09/2020 |
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| 576 | Allopurinol | INDOCO REMEDIES LIMITED Mumbai IN | 100020134;100061295 | CEP 2008-017 - Rev 05 | 2025/03/28 | Valid | Chemical | 2025/03/28 | Minor revision|CEP granted|28/03/2025; Notification|CEP granted|20/11/2023; Minor revision|Accepted - CEP remains valid|09/09/2021 |
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| 1280 | Zolpidem tartrate | Farmak A.S. Olomouc CZ | 100012043;100022687 | CEP 2000-319 - Rev 06 | 2025/03/28 | Valid | Chemical | 2025/03/28 | Minor revision|CEP granted|28/03/2025; Minor revision|CEP granted|02/02/2024; Notification|Accepted - CEP remains valid|12/04/2022; Notification|Accepted - CEP remains valid|29/10/2021; Minor revision|Accepted - CEP remains valid|04/11/2020; Monograph revision|Accepted - CEP remains valid|19/05/2020 |
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| 2640 | Atomoxetine hydrochloride, Form-A, Process II | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2020-091 - Rev 02 | 2025/03/28 | Valid | Chemical | 2025/03/28 | Renewal|CEP granted|28/03/2025; Major revision|CEP granted|19/03/2021; New application|CEP granted|02/06/2020 |
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| 2414 | Octreotide | AURO PEPTIDES LIMITED Kandi Mandal IN | 100049810;100086899 | CEP 2023-017 - Rev 00 | 2025/03/28 | Valid | 28/03/2030 | Chemical | 2025/03/28 | New application|CEP granted|28/03/2025 | |
| 1696 | Flunixin meglumine for veterinary use, Process-II | SEQUENT SCIENTIFIC LIMITED Mumbai IN | 100017805;100032372 | CEP 2022-371 - Rev 04 | 2025/03/28 | Valid | 05/01/2028 | Chemical | 2025/03/28 | Minor revision|CEP granted|28/03/2025; Minor revision|CEP granted|04/04/2024; Minor revision|CEP granted|25/05/2023; Notification|CEP granted|30/03/2023; New application|CEP granted|05/01/2023 |
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| 576 | Allopurinol | ASSURGEN PHARMA PRIVATE LIMITED Lalamkoduru Village IN | 100048048;100079469 | CEP 2022-390 - Rev 00 | 2025/03/28 | Valid | 28/03/2030 | Chemical | 2025/03/28 | New application|CEP granted|28/03/2025 | |
| 2017 | Oxaliplatin, Process-II | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2024-552 - Rev 00 | 2025/03/28 | Valid | 28/03/2030 | Chemical | 2025/03/28 | New application|CEP granted|28/03/2025 |
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