| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 576 | Allopurinol | ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN | 100048048;100101722 | CEP 2022-390 - Rev 01 | 2026/04/10 | Valid | 28/03/2030 | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; New application|CEP granted|28/03/2025 |
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| 542 | Busulfan | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2013-341 - Rev 02 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; Notification|CEP granted|31/08/2023; Renewal|CEP granted|23/02/2021 |
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| 573 | Verapamil hydrochloride | ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN | 100048048;100101722 | CEP 2019-014 - Rev 03 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; Renewal|CEP granted|13/01/2026; Minor revision|CEP granted|20/02/2023 |
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| 2296 | Pantoprazole sodium sesquihydrate | ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN | 100048048;100101722 | CEP 2018-199 - Rev 02 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; Renewal|CEP granted|04/03/2025 |
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| 2576 | Voriconazole, Form-I | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2018-184 - Rev 03 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Major revision|CEP granted|10/04/2026; Renewal|Accepted - CEP remains valid|24/11/2025; Minor revision|CEP granted|16/09/2024; Major revision|CEP granted|01/12/2022; Minor revision|Rejected|02/03/2022 |
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| 140 | Ethinylestradiol, Dorog site | GEDEON RICHTER PLC. Budapest X HU | 100000640;100001653 | CEP 2025-497 - Rev 00 | 2026/04/10 | Valid | 10/04/2031 | Chemical | 2026/04/10 | New application|CEP granted|10/04/2026 | |
| 140 | Ethinylestradiol, Micronised, Dorog site | GEDEON RICHTER PLC. Budapest X HU | 100000640;100001653 | CEP 2025-556 - Rev 00 | 2026/04/10 | Valid | 10/04/2031 | Chemical | 2026/04/10 | New application|CEP granted|10/04/2026 | |
| 2787 | Esomeprazole magnesium dihydrate, Micronised, Non-micronised | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2023-283 - Rev 01 | 2026/04/10 | Valid | 18/12/2029 | Chemical | 2026/04/10 | Minor revision|CEP granted|10/04/2026; New application|CEP granted|18/12/2024 |
|
| 2577 | Oxcarbazepine | ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN | 100048048;100101722 | CEP 2023-450 - Rev 01 | 2026/04/10 | Valid | 12/11/2030 | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; New application|CEP granted|12/11/2025 |
|
| 678 | Sodium valproate, Process 2 | ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN | 100048048;100101722 | CEP 2024-562 - Rev 01 | 2026/04/10 | Valid | 28/03/2030 | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; New application|CEP granted|28/03/2025 |
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| 2992 | Lacosamide, Shijiazhuang Site, process B | BEIJING HOPE PHARMACEUTICAL CO., LTD. Beijing CN | 100050494;100088152 | CEP 2025-593 - Rev 00 | 2026/04/10 | Valid | 10/04/2031 | Chemical | 2026/04/10 | New application|CEP granted|10/04/2026 | |
| 1745 | Carvedilol, Synthetic route B | EGIS PHARMACEUTICALS PLC. Budapest X HU | 100001091;100001662 | CEP 2016-314 - Rev 01 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; Renewal|CEP granted|28/08/2023; Major revision|CEP granted|02/08/2022; Minor revision|CEP granted|26/08/2020 |
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| 768 | Hydrocortisone hydrogen succinate | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2014-120 - Rev 03 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; Notification|CEP granted|12/01/2026; Minor revision|Accepted - CEP remains valid|07/07/2023; Minor revision|CEP granted|19/08/2021; Renewal|CEP granted|18/02/2021 |
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| 1131 | Methylprednisolone hydrogen succinate | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2009-187 - Rev 05 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Notification|CEP granted|10/04/2026; Notification|Accepted - CEP remains valid|19/01/2026; Administrative procedure|CEP granted|30/01/2023; Minor revision|Accepted - CEP remains valid|19/01/2023; Notification|CEP granted|11/05/2021; Notification|Accepted - CEP remains valid|12/10/2020 |
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| 627 | Nifedipine | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2014-102 - Rev 02 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Monograph revision|CEP granted|10/04/2026; Minor revision|CEP granted|20/02/2023; Minor revision|Accepted - CEP remains valid|08/11/2021; Renewal|CEP granted|13/01/2021 |
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| 53 | Streptomycin sulfate | HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang CN | 100016575;100025368 | CEP 2004-052 - Rev 04 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Minor revision|CEP granted|10/04/2026; Minor revision|Accepted - CEP remains valid|17/05/2023; Minor revision|Accepted - CEP remains valid|01/12/2021; Notification|CEP granted|09/09/2021; Monograph revision|Accepted - CEP remains valid|11/02/2021 |
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| 38 | Levodopa, Micronised I, micronised II and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2017-090 - Rev 05 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Major revision|CEP granted|10/04/2026; Notification|Accepted - CEP remains valid|13/11/2024; Renewal|CEP granted|24/04/2024; Minor revision|Accepted - CEP remains valid|28/08/2023; Minor revision|Accepted - CEP remains valid|28/10/2022; Minor revision|CEP granted|08/12/2021; Major revision|CEP granted|30/07/2020 |
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| 1089 | Ciprofloxacin | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN | 100022562;100093113 | CEP 2020-120 - Rev 04 | 2026/04/10 | Valid | Chemical | 2026/04/10 | Renewal|CEP granted|10/04/2026; Minor revision|CEP granted|17/01/2025; Minor revision|CEP granted|03/07/2024; Minor revision|CEP granted|26/10/2022; New application|CEP granted|11/06/2021 |
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| 2775 | Nebivolol hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2021-403 - Rev 02 | 2026/04/10 | Valid | 06/07/2027 | Chemical | 2026/04/10 | Minor revision|CEP granted|10/04/2026; Minor revision|Accepted - CEP remains valid|21/10/2025; Notification|CEP granted|03/12/2024; Minor revision|Accepted - CEP remains valid|16/02/2023; New application|CEP granted|06/07/2022 |
|
| 730 | Naphazoline Hydrochloride | C-SQUARED PHARMA LIMITED Cork IE | 100045238;100077698 | CEP 2024-411 - Rev 00 | 2026/04/10 | Valid | 10/04/2031 | Chemical | 2026/04/10 | New application|CEP granted|10/04/2026 |
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