| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3132 | Mirabegron | ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Jinhua CN | 100012165;100019516 | CEP 2024-037 - Rev 00 | 2025/05/30 | Valid | 30/05/2030 | Chemical | 2025/05/30 | New application|CEP granted|30/05/2025 | |
| 2858 | Mometasone furoate monohydrate | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | 100018877;100092992 | CEP 2021-233 - Rev 02 | 2025/05/30 | Valid | 10/05/2027 | Chemical | 2025/10/06 | Minor revision|Accepted - CEP remains valid|06/10/2025; Minor revision|CEP granted|30/05/2025; Notification|CEP granted|18/01/2023; Notification|Accepted - CEP remains valid|14/06/2022; New application|CEP granted|10/05/2022 |
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| 1699 | Mesalazine, Regular density | BEC CHEMICALS PRIVATE LIMITED Mumbai IN | 100016436;100025221 | CEP 2019-299 - Rev 01 | 2025/05/30 | Valid | Chemical | 2025/07/23 | Renewal|Accepted - CEP remains valid|23/07/2025; Minor revision|CEP granted|30/05/2025; Minor revision|Accepted - CEP remains valid|31/07/2024; Minor revision|Accepted - CEP remains valid|18/04/2023 |
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| 1688 | Articaine hydrochloride | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2015-311 - Rev 02 | 2025/05/30 | Valid | Chemical | 2025/05/30 | Minor revision|CEP granted|30/05/2025; Notification|CEP granted|16/12/2022; Renewal|CEP granted|15/12/2021 |
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| 989 | Cefotaxime sodium, Sterile, Process 2 | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2020-406 - Rev 01 | 2025/05/30 | Valid | 18/11/2027 | Chemical | 2025/05/30 | Minor revision|CEP granted|30/05/2025; New application|CEP granted|21/11/2022 |
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| 2235 | Methylphenidate hydrochloride, Process II | JANSSEN PHARMACEUTICA NV Beerse BE | 100000625;100005958 | CEP 2024-590 - Rev 00 | 2025/05/30 | Valid | 30/05/2030 | Chemical | 2025/05/30 | New application|CEP granted|30/05/2025 | |
| 2338 | Mirtazapine, Process-II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2025-118 - Rev 00 | 2025/05/30 | Valid | 30/05/2030 | Chemical | 2025/05/30 | New application|CEP granted|30/05/2025 | |
| 1700 | Mycophenolate mofetil | TAPI CZECH INDUSTRIES S.R.O. Opava CZ | 100051642;100090678 | CEP 2005-239 - Rev 06 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Notification|CEP granted|28/05/2025; Minor revision|CEP granted|09/01/2025; Notification|CEP granted|27/11/2020 |
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| 1449 | Mometasone furoate | STERLING S.p.A. Solomeo Di Corciano IT | 100024377;100033551 | CEP 2006-301 - Rev 05 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Notification|CEP granted|28/05/2025; Minor revision|CEP granted|24/03/2022; Minor revision|CEP granted|27/08/2021 |
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| 20 | Dextromethorphan hydrobromide monohydrate | HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED Secunderabad IN | 100024077;100041595 | CEP 2014-023 - Rev 01 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Monograph revision|CEP granted|28/05/2025; Monograph revision|Accepted - CEP remains valid|02/05/2024; Minor revision|Accepted - CEP remains valid|29/06/2023; Minor revision|Accepted - CEP remains valid|23/06/2021; Renewal|CEP granted|23/07/2020 |
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| 2296 | Pantoprazole sodium sesquihydrate | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2008-323 - Rev 05 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Minor revision|CEP granted|28/05/2025; Administrative procedure|CEP granted|11/05/2022; Notification|CEP granted|03/05/2022; Minor revision|Accepted - CEP remains valid|17/09/2021; Minor revision|CEP granted|18/11/2020 |
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| 2777 | Pregabalin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2017-165 - Rev 02 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Minor revision|CEP granted|28/05/2025; Notification|CEP granted|14/03/2025; Renewal|CEP granted|18/07/2023; Minor revision|CEP granted|29/11/2022; Minor revision|CEP granted|29/11/2021 |
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| 2573 | Candesartan cilexetil, Process-IV | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2019-297 - Rev 03 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Renewal|CEP granted|28/05/2025; Notification|Accepted - CEP remains valid|25/01/2023; Minor revision|CEP granted|28/02/2022; Minor revision|Accepted - CEP remains valid|12/08/2021; Minor revision|Accepted - CEP remains valid|29/03/2021; Minor revision|CEP granted|09/10/2020 |
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| 1169 | Piperacillin monohydrate | SHANDONG ANSHUN PHARMACEUTICAL CO., LTD. Dezhou City CN | 100039958;100064554 | CEP 2019-153 - Rev 03 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Renewal|CEP granted|28/05/2025; Minor revision|CEP granted|31/07/2024; Minor revision|Accepted - CEP remains valid|16/09/2021; Monograph revision|CEP granted|16/04/2021 |
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| 2600 | Olmesartan medoxomil, Process II | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2016-111 - Rev 01 | 2025/05/28 | Valid | Chemical | 2025/05/28 | Major revision|CEP granted|28/05/2025; Renewal|CEP granted|14/04/2022 |
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| 749 | Vincristine sulfate | Fine Chemicals Corporation (Pty) Ltd. Goodwood ZA | 100025016;100034210 | CEP 2021-387 - Rev 01 | 2025/05/28 | Valid | 05/04/2029 | Chemical | 2025/05/28 | Minor revision|CEP granted|28/05/2025; New application|CEP granted|05/04/2024 |
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| 2778 | Sitagliptin phosphate monohydrate, Process-II | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2025-087 - Rev 00 | 2025/05/28 | Valid | 28/05/2030 | Chemical | 2025/05/28 | New application|CEP granted|28/05/2025 | |
| 1491 | Amlodipine besilate, ADP process | UNICHEM LABORATORIES LIMITED Mumbai IN | 100005397;100093080 | CEP 2024-371 - Rev 00 | 2025/05/28 | Valid | 28/05/2030 | Chemical | 2025/05/28 | New application|CEP granted|28/05/2025 | |
| 2421 | Ziprasidone hydrochloride monohydrate | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2011-196 - Rev 02 | 2025/05/27 | Valid | Chemical | 2025/05/27 | Notification|CEP granted|27/05/2025; Notification|Accepted - CEP remains valid|20/07/2022; Major revision|CEP granted|24/07/2020 |
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| 2591 | Celecoxib | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2012-388 - Rev 04 | 2025/05/27 | Valid | Chemical | 2025/05/27 | Minor revision|CEP granted|27/05/2025; Minor revision|Accepted - CEP remains valid|04/09/2023; Notification|Accepted - CEP remains valid|19/01/2023; Minor revision|CEP granted|29/03/2022; Minor revision|CEP granted|09/04/2020 |
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