| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1140 | Potassium clavulanate | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN | 100033465;100082197 | CEP 2014-320 - Rev 01 | 2025/06/02 | Valid | Chemical | 2025/06/02 | Minor revision|CEP granted|02/06/2025; Renewal|CEP granted|05/03/2021 |
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| 654 | Beclometasone dipropionate | AVIK PHARMACEUTICAL LIMITED Vapi IN | 100023327;100041968 | CEP 2014-036 - Rev 02 | 2025/06/02 | Valid | Chemical | 2025/06/02 | Minor revision|CEP granted|02/06/2025; Major revision|CEP granted|30/07/2024; Notification|Accepted - CEP remains valid|17/06/2022; Renewal|CEP granted|03/11/2020 |
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| 1705 | Sertraline hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2008-265 - Rev 02 | 2025/06/02 | Valid | Chemical | 2025/06/02 | Minor revision|CEP granted|02/06/2025; Notification|Accepted - CEP remains valid|28/07/2021; Minor revision|Accepted - CEP remains valid|05/01/2021; Notification|CEP granted|27/05/2020 |
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| 576 | Allopurinol | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2008-211 - Rev 05 | 2025/06/02 | Valid | Chemical | 2025/06/02 | Minor revision|CEP granted|02/06/2025; Minor revision|Accepted - CEP remains valid|12/03/2024; Minor revision|CEP granted|27/01/2023; Minor revision|Accepted - CEP remains valid|21/02/2022; Minor revision|CEP granted|19/08/2020 |
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| 729 | Naloxone hydrochloride dihydrate | NORAMCO, LLC. Wilmington US | 100048651;100080628 | CEP 2011-055 - Rev 04 | 2025/06/02 | Valid | Chemical | 2025/06/02 | Minor revision|CEP granted|02/06/2025; Minor revision|CEP granted|06/09/2023; Notification|CEP granted|18/03/2022; Notification|CEP granted|05/03/2020 |
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| 3139 | Brivaracetam | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2024-088 - Rev 00 | 2025/06/02 | Valid | 02/06/2030 | Chemical | 2025/06/02 | New application|CEP granted|02/06/2025 | |
| 2760 | Brimonidine tartrate | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2019-335 - Rev 03 | 2025/06/02 | Valid | Chemical | 2025/06/02 | Renewal|CEP granted|02/06/2025; Notification|CEP granted|18/04/2024; Major revision|CEP granted|07/02/2022; Minor revision|Rejected|17/11/2021 |
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| 1354 | Oxybutynin hydrochloride | THINQ PHARMA-CRO LIMITED Thane IN | 100042194;100069636 | CEP 2024-057 - Rev 00 | 2025/06/02 | Valid | 02/06/2030 | Chemical | 2025/06/02 | New application|CEP granted|02/06/2025 | |
| 714 | Doxorubicin Hydrochloride | DZD (HEZE) PHARMACEUTICAL CO., LTD. Heze City CN | 100039412;100062056 | CEP 2016-254 - Rev 01 | 2025/06/02 | Valid | Chemical | 2025/06/02 | Minor revision|CEP granted|02/06/2025; Renewal|CEP granted|22/11/2022 |
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| 2849 | Hydroxychloroquine sulfate | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2019-011 - Rev 02 | 2025/06/02 | Valid | Chemical | 2025/10/24 | Minor revision|Accepted - CEP remains valid|24/10/2025; Renewal|CEP granted|02/06/2025; Minor revision|Accepted - CEP remains valid|20/09/2024; Notification|CEP granted|08/07/2022; Minor revision|Accepted - CEP remains valid|15/09/2020 |
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| 2992 | Lacosamide, Process II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-128 - Rev 02 | 2025/06/02 | Valid | 04/07/2029 | Chemical | 2025/06/02 | Administrative procedure|CEP granted|02/06/2025; Minor revision|CEP granted|26/05/2025; New application|CEP granted|04/07/2024 |
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| 3095 | Dabigatran etexilate mesilate, Form-I | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2024-262 - Rev 00 | 2025/06/02 | Valid | 02/06/2030 | Chemical | 2025/06/02 | New application|CEP granted|02/06/2025 | |
| 2762 | Capecitabine, Process-III | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2025-176 - Rev 00 | 2025/06/02 | Valid | 02/06/2030 | Chemical | 2025/06/02 | New application|CEP granted|02/06/2025 | |
| 2585 | Rizatriptan benzoate, 1295 | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2025-054 - Rev 00 | 2025/06/02 | Valid | 02/06/2030 | Chemical | 2025/06/02 | New application|CEP granted|02/06/2025 | |
| 778 | Oxazepam | R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN | 100016723;100053383 | CEP 2024-383 - Rev 00 | 2025/06/02 | Valid | 02/06/2030 | Chemical | 2025/06/02 | New application|CEP granted|02/06/2025 | |
| 2173 | Gabapentin, Process V | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2024-148 - Rev 01 | 2025/06/02 | Valid | 19/07/2029 | Chemical | 2025/06/02 | Minor revision|CEP granted|02/06/2025; New application|CEP granted|19/07/2024 |
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| 1558 | Propofol | SI GROUP, INC. The Woodlands US | 100025308;100077018 | CEP 2002-229 - Rev 05 | 2025/05/30 | Valid | Chemical | 2025/05/30 | Minor revision|CEP granted|30/05/2025; Minor revision|CEP granted|26/10/2023; Notification|CEP granted|22/08/2022 |
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| 2541 | Quetiapine Fumarate | MEGA FINE PHARMA PRIVATE LIMITED Mumbai IN | 100011550;100021133 | CEP 2014-198 - Rev 02 | 2025/05/30 | Valid | Chemical | 2025/05/30 | Minor revision|CEP granted|30/05/2025; Minor revision|CEP granted|21/11/2023 |
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| 1632 | Celiprolol hydrochloride | MOEHS IBERICA S.L. Rubi ES | 100029092;100068825 | CEP 2007-220 - Rev 05 | 2025/05/30 | Valid | Chemical | 2025/05/30 | Minor revision|CEP granted|30/05/2025; Minor revision|CEP granted|08/03/2024; Minor revision|Accepted - CEP remains valid|24/10/2022; Monograph revision|CEP granted|24/03/2021 |
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| 2421 | Ziprasidone hydrochloride monohydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2012-131 - Rev 02 | 2025/05/30 | Valid | Chemical | 2025/05/30 | Minor revision|CEP granted|30/05/2025; Notification|CEP granted|11/01/2024; Minor revision|Accepted - CEP remains valid|17/11/2021; Minor revision|Accepted - CEP remains valid|29/04/2021 |
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