| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 401 | Levothyroxine sodium | VALARY LAB PRIVATE LIMITED Visakhapatnam IN | 100047829;100079089 | CEP 2023-230 - Rev 00 | 2025/07/03 | Valid | 03/07/2030 | Chemical | 2025/07/03 | New application|CEP granted|03/07/2025 | |
| 2591 | Celecoxib | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2012-286 - Rev 02 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Minor revision|CEP granted|03/07/2025 | ||
| 2191 | Atorvastatin calcium | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2012-035 - Rev 03 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Minor revision|CEP granted|03/07/2025; Notification|Accepted - CEP remains valid|26/02/2024; Monograph revision|CEP granted|22/08/2022; Notification|CEP granted|20/12/2021 |
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| 755 | Carbidopa | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2001-352 - Rev 09 | 2025/07/03 | Valid | Chemical | 2025/07/03 | Notification|CEP granted|03/07/2025; Notification|CEP granted|31/07/2023; Notification|CEP granted|24/03/2022; Notification|CEP granted|20/12/2021; Notification|CEP granted|19/02/2021 |
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| 2531 | Clopidogrel hydrogen sulfate, Form-I, non-micronised and micronised | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2012-059 - Rev 03 | 2025/07/01 | Valid | Chemical | 2025/07/01 | Minor revision|CEP granted|01/07/2025; Minor revision|Accepted - CEP remains valid|06/06/2024; Minor revision|CEP granted|27/09/2022; Minor revision|CEP granted|22/10/2021; Minor revision|Accepted - CEP remains valid|01/07/2020 |
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| 115 | Benzylpenicillin (procaine) monohydrate, Sterile with lecithin and polysorbate | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL | 100002351;100005259 | CEP 2024-202 - Rev 00 | 2025/07/01 | Valid | 01/07/2030 | Chemical | 2025/07/01 | New application|CEP granted|01/07/2025 | |
| 2119 | Venlafaxine hydrochloride, Crystalline Form-C | MSN LIFE SCIENCES PRIVATE LIMITED Medak IN | 100018316;100027671 | CEP 2024-250 - Rev 00 | 2025/07/01 | Valid | 01/07/2030 | Chemical | 2025/07/01 | New application|CEP granted|01/07/2025 | |
| 2535 | Levetiracetam, Process-II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-491 - Rev 01 | 2025/07/01 | Valid | 20/06/2030 | Chemical | 2025/07/01 | Administrative procedure|CEP granted|01/07/2025; New application|CEP granted|20/06/2025 |
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| 2736 | Imatinib mesilate, FORM-ALPHA (IF process) | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2024-574 - Rev 00 | 2025/07/01 | Valid | 01/07/2030 | Chemical | 2025/07/01 | New application|CEP granted|01/07/2025 | |
| . | Bovine pericardium | SUZHOU CARDIOFIX BIOTECH CO. LTD. Suzhou CN | 100053702;100094972 | CEP 2025-055 - Rev 00 | 2025/06/30 | Valid | 30/06/2030 | TSE | 2025/06/30 | New application|CEP granted|30/06/2025 | |
| . | Foetal Bovine Serum | SUZHOU EXCELL BIOTECHNOLOGY CO. LTD. Taicang CN | 100050525;100088216 | CEP 2024-420 - Rev 00 | 2025/06/30 | Valid | 30/06/2030 | TSE | 2025/06/30 | New application|CEP granted|30/06/2025 | |
| 2017 | Oxaliplatin | DEBIOPHARM INTERNATIONAL S.A. Lausanne CH | 100006274;100012184 | CEP 2003-229 - Rev 06 | 2025/06/30 | Valid | Chemical | 2025/06/30 | Minor revision|CEP granted|30/06/2025; Minor revision|Accepted - CEP remains valid|06/06/2024; Minor revision|CEP granted|18/10/2022; Major revision|Accepted - CEP remains valid|23/06/2021 |
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| 576 | Allopurinol, Allopurinol P-process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2014-117 - Rev 03 | 2025/06/30 | Valid | Chemical | 2025/06/30 | Notification|CEP granted|30/06/2025; Minor revision|CEP granted|16/02/2024; Minor revision|CEP granted|29/03/2022; Minor revision|Accepted - CEP remains valid|18/11/2020 |
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| 2330 | Leflunomide, Micronised | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2007-172 - Rev 03 | 2025/06/30 | Valid | Chemical | 2025/06/30 | Minor revision|CEP granted|30/06/2025; Minor revision|Accepted - CEP remains valid|05/09/2024; Notification|Accepted - CEP remains valid|03/02/2023; Minor revision|Accepted - CEP remains valid|04/03/2020 |
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| 1104 | Fluoxetine hydrochloride | CADILA PHARMACEUTICALS LIMITED Ankleshwar IN | 100003616;100000498 | CEP 2004-207 - Rev 07 | 2025/06/30 | Valid | Chemical | 2025/06/30 | Minor revision|CEP granted|30/06/2025; Minor revision|CEP granted|07/03/2022; Monograph revision|CEP granted|01/04/2021 |
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| 654 | Beclometasone dipropionate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-108 - Rev 06 | 2025/06/30 | Valid | Chemical | 2025/06/30 | Notification|CEP granted|30/06/2025; Minor revision|Accepted - CEP remains valid|11/07/2024; Minor revision|CEP granted|31/10/2023; Minor revision|CEP granted|24/06/2022; Notification|CEP granted|20/12/2021 |
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| 2536 | Milbemycin oxime for veterinary use, Process-II | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2020-124 - Rev 03 | 2025/06/30 | Valid | Chemical | 2025/06/30 | Renewal|CEP granted|30/06/2025; Minor revision|CEP granted|13/05/2022; Minor revision|CEP granted|04/03/2021; New application|CEP granted|14/09/2020 |
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| 2232 | Losartan potassium | MSN LIFE SCIENCES PRIVATE LIMITED Medak IN | 100018316;100027671 | CEP 2021-299 - Rev 01 | 2025/06/30 | Valid | 09/03/2028 | Chemical | 2025/06/30 | Minor revision|CEP granted|30/06/2025; New application|CEP granted|09/03/2023 |
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| 863 | Sulfasalazine | VALENS MOLECULES PRIVATE LIMITED Hyderabad IN | 100038865;100061080 | CEP 2016-085 - Rev 01 | 2025/06/30 | Valid | Chemical | 2025/06/30 | Major revision|CEP granted|30/06/2025; Renewal|CEP granted|19/01/2023 |
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| 976 | Bleomycin Sulfate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2021-272 - Rev 02 | 2025/06/30 | Valid | 31/08/2028 | Chemical | 2025/06/30 | Notification|CEP granted|30/06/2025; Minor revision|CEP granted|28/06/2024; New application|CEP granted|05/09/2023 |
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