| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2270 | Sildenafil citrate, Micronised and non-micronised | MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN | 100012074;100018617 | CEP 2013-219 - Rev 02 | 2026/03/13 | Valid | Chemical | 2026/03/13 | Minor revision|CEP granted|13/03/2026; Minor revision|CEP granted|13/12/2021; Notification|Accepted - CEP remains valid|25/05/2020 |
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| 3151 | Cannabidiol | BSPG LABORATORIES LIMITED Sandwich GB | 100033275;100051938 | CEP 2024-370 - Rev 00 | 2026/03/13 | Valid | 13/03/2031 | Chemical | 2026/03/13 | New application|CEP granted|13/03/2026 | |
| 1335 | Itraconazole, Unit IV (I) | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2026-004 - Rev 00 | 2026/03/13 | Valid | 13/03/2031 | Chemical | 2026/03/13 | New application|CEP granted|13/03/2026 | |
| 272 | Doxycycline hyclate | SHANDONG GUOBANG PHARMACEUTICAL CO., LTD. Weifang CN | 100036834;100058198 | CEP 2022-336 - Rev 01 | 2026/03/13 | Valid | 25/09/2029 | Chemical | 2026/03/13 | Minor revision|CEP granted|13/03/2026; New application|CEP granted|25/09/2024 |
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| 1373 | Testosterone, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2015-314 - Rev 02 | 2026/03/12 | Valid | Chemical | 2026/03/12 | Notification|CEP granted|12/03/2026; Notification|Accepted - CEP remains valid|15/11/2023; Minor revision|CEP granted|30/06/2023; Renewal|CEP granted|15/06/2022; Minor revision|Accepted - CEP remains valid|18/10/2021; Monograph revision|CEP granted|27/07/2020 |
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| 2331 | Rabeprazole sodium hydrate | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2018-158 - Rev 02 | 2026/03/12 | Valid | Chemical | 2026/03/12 | Notification|CEP granted|12/03/2026; Minor revision|Accepted - CEP remains valid|18/06/2025; Renewal|CEP granted|30/10/2024 |
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| 2219 | Lansoprazole, Unit IV | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2020-185 - Rev 02 | 2026/03/12 | Valid | Chemical | 2026/03/12 | Notification|CEP granted|12/03/2026; Renewal|CEP granted|25/06/2025; New application|CEP granted|26/08/2020 |
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| 2541 | Quetiapine Fumarate | ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. Dongyang CN | 100022699;100078733 | CEP 2025-013 - Rev 00 | 2026/03/12 | Valid | 12/03/2031 | Chemical | 2026/03/12 | New application|CEP granted|12/03/2026 | |
| 2531 | Clopidogrel hydrogen sulfate, Form II, Process 3 | SYNTHIMED LABS PRIVATE LIMITED Derabassi IN | 100052287;100092080 | CEP 2026-032 - Rev 00 | 2026/03/12 | Valid | 12/03/2031 | Chemical | 2026/03/12 | New application|CEP granted|12/03/2026 | |
| 1773 | Cabergoline | LIFECARE LABORATORIES PRIVATE LIMITED Hyderabad IN | 100049798;100086853 | CEP 2023-093 - Rev 00 | 2026/03/12 | Valid | 12/03/2031 | Chemical | 2026/03/12 | New application|CEP granted|12/03/2026 | |
| 49 | Paracetamol | IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN | 100017919;100037377 | CEP 2022-085 - Rev 01 | 2026/03/12 | Valid | 03/05/2028 | Chemical | 2026/03/12 | Minor revision|CEP granted|12/03/2026; Minor revision|Accepted - CEP remains valid|22/08/2025; Minor revision|Rejected|01/07/2025; Major revision|Accepted - CEP remains valid|16/11/2023; New application|CEP granted|03/05/2023 |
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| 2191 | Atorvastatin calcium, TBAH Sulphate Route, Vijayasri Organics | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-464 - Rev 00 | 2026/03/11 | Valid | 11/03/2031 | Chemical | 2026/03/11 | New application|CEP granted|11/03/2026 | |
| 3095 | Dabigatran etexilate mesilate, Form I, ACL | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2025-606 - Rev 00 | 2026/03/11 | Valid | 11/03/2031 | Chemical | 2026/03/11 | New application|CEP granted|11/03/2026 | |
| 1490 | Amisulpride, Process 2 | ICROM S.R.L. Concorezzo IT | 100022464;100031145 | CEP 2019-051 - Rev 05 | 2026/03/11 | Valid | Chemical | 2026/03/11 | Minor revision|CEP granted|11/03/2026; Renewal|CEP granted|18/09/2024; Notification|CEP granted|21/11/2023; Minor revision|CEP granted|30/03/2021; Notification|CEP granted|27/11/2020; Notification|Accepted - CEP remains valid|24/08/2020 |
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| 821 | Estradiol hemihydrate, Process B, micronised | SHAANXI HANJIANG PHARMACEUTICAL GROUP CO., LTD. Hanzhong CN | 100012369;100079669 | CEP 2023-179 - Rev 01 | 2026/03/11 | Valid | 25/09/2029 | Chemical | 2026/03/11 | Minor revision|CEP granted|11/03/2026; Major revision|Accepted - CEP remains valid|28/03/2025; New application|CEP granted|25/09/2024 |
|
| 714 | Doxorubicin Hydrochloride | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2012-367 - Rev 03 | 2026/03/11 | Valid | Chemical | 2026/03/11 | Minor revision|CEP granted|11/03/2026; Notification|Accepted - CEP remains valid|13/10/2025; Minor revision|CEP granted|20/03/2024 |
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| 780 | Oxytocin | SHENZHEN JYMED TECHNOLOGY CO., LTD. Shenzhen CN | 100042374;100070008 | CEP 2015-376 - Rev 01 | 2026/03/11 | Valid | Chemical | 2026/03/11 | Minor revision|CEP granted|11/03/2026; Monograph revision|Accepted - CEP remains valid|12/12/2023; Renewal|CEP granted|07/11/2022; Minor revision|CEP granted|28/05/2020 |
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| 1700 | Mycophenolate mofetil | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2019-089 - Rev 03 | 2026/03/11 | Valid | 24/08/2026 | Chemical | 2026/03/11 | Notification|CEP granted|11/03/2026; Notification|Rejected|31/10/2024; Minor revision|CEP granted|21/04/2023; Minor revision|CEP granted|10/02/2022 |
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| 931 | Metformin Hydrochloride, Process-II | IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN | 100017919;100037377 | CEP 2025-564 - Rev 01 | 2026/03/11 | Valid | 05/03/2031 | Chemical | 2026/03/11 | Administrative procedure|CEP granted|11/03/2026; New application|CEP granted|05/03/2026 |
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| 2932 | Rivaroxaban | BAJAJ HEALTHCARE LIMITED Thane IN | 100021782;100061986 | CEP 2023-085 - Rev 01 | 2026/03/11 | Valid | 30/04/2030 | Chemical | 2026/03/11 | Minor revision|CEP granted|11/03/2026; New application|CEP granted|30/04/2025 |
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