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 |
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1491 | Amlodipine besilate | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2003-007 - Rev 07 | 2025/06/06 | Valid | Chemical | 2025/06/06 | Minor revision|CEP granted|06/06/2025 | ||
616 | Haloperidol | MANKIND PHARMA LIMITED New Delhi IN | 100045169;100074533 | CEP 2020-026 - Rev 02 | 2025/06/06 | Valid | 05/01/2027 | Chemical | 2025/06/06 | Notification|CEP granted|06/06/2025; Major revision|CEP granted|22/02/2024; New application|CEP granted|05/01/2022 |
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2787 | Esomeprazole magnesium dihydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2014-333 - Rev 03 | 2025/06/06 | Valid | Chemical | 2025/06/06 | Notification|CEP granted|06/06/2025; Minor revision|CEP granted|08/01/2025; Notification|CEP granted|07/03/2023; Renewal|CEP granted|26/04/2022; Minor revision|CEP granted|11/03/2020 |
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1431 | Haloperidol decanoate | MANKIND PHARMA LIMITED New Delhi IN | 100045169;100074533 | CEP 2020-080 - Rev 02 | 2025/06/06 | Valid | 20/05/2027 | Chemical | 2025/06/06 | Notification|CEP granted|06/06/2025; Minor revision|Accepted - CEP remains valid|08/11/2024; Major revision|CEP granted|30/08/2024; New application|CEP granted|20/05/2022 |
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533 | Triamcinolone acetonide | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2022-255 - Rev 00 | 2025/06/06 | Valid | 06/06/2030 | Chemical | 2025/06/06 | New application|CEP granted|06/06/2025 | |
1519 | Flurbiprofen | Wisdom Pharmaceutical Co., Ltd. Haimen CN | 100014837;100023467 | CEP 2024-024 - Rev 00 | 2025/06/06 | Valid | 06/06/2030 | Chemical | 2025/06/06 | New application|CEP granted|06/06/2025 | |
2191 | Atorvastatin calcium, Trihydrate | MANKIND PHARMA LIMITED New Delhi IN | 100045169;100074533 | CEP 2022-262 - Rev 01 | 2025/06/06 | Valid | 16/02/2029 | Chemical | 2025/06/06 | Notification|CEP granted|06/06/2025; New application|CEP granted|16/02/2024 |
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2866 | Gefitinib | ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. Taizhou CN | 100011841;100018560 | CEP 2018-236 - Rev 02 | 2025/06/05 | Valid | Chemical | 2025/06/05 | Renewal|CEP granted|05/06/2025; Minor revision|CEP granted|02/02/2022; Minor revision|Accepted - CEP remains valid|19/08/2021 |
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333 | Heparin sodium, For parenteral preparations | YANTAI DONGCHENG BIOCHEMICALS CO. LTD. Yantai CN | 100022810;100052422 | CEP 2003-197 - Rev 11 | 2025/06/05 | Valid | Chemical | 2025/06/05 | Major revision|CEP granted|05/06/2025; Monograph revision|Accepted - CEP remains valid|13/06/2024; Major revision|CEP granted|28/09/2022; Major revision|CEP granted|21/01/2022 |
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1699 | Mesalazine | BEC CHEMICALS PRIVATE LIMITED Mumbai IN | 100016436;100025221 | CEP 2011-100 - Rev 01 | 2025/06/05 | Valid | Chemical | 2025/06/05 | Minor revision|CEP granted|05/06/2025; Minor revision|Accepted - CEP remains valid|31/07/2024; Minor revision|Accepted - CEP remains valid|18/04/2023; Minor revision|Accepted - CEP remains valid|09/10/2020 |
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946 | Ranitidine hydrochloride, Crystalline powder grade and D.C. grade | ORCHEV PHARMA PRIVATE LIMITED Rajkot IN | 100020650;100029403 | CEP 2007-320 - Rev 03 | 2025/06/05 | Valid | Chemical | 2025/06/05 | |||
925 | Levomepromazine maleate | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2018-144 - Rev 05 | 2025/06/05 | Valid | Chemical | 2025/06/05 | Minor revision|CEP granted|05/06/2025; Renewal|Accepted - CEP remains valid|24/03/2025; Notification|CEP granted|10/07/2024; Minor revision|Accepted - CEP remains valid|09/04/2024; Monograph revision|CEP granted|09/08/2023; Notification|CEP granted|12/02/2021; Minor revision|CEP granted|07/08/2020 |
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1651 | Clarithromycin, Form-II (Process-II) | SYNTHIMED LABS PRIVATE LIMITED Derabassi IN | 100052287;100092080 | CEP 2024-435 - Rev 01 | 2025/06/05 | Valid | 11/03/2030 | Chemical | 2025/06/05 | Minor revision|CEP granted|05/06/2025; New application|CEP granted|11/03/2025 |
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396 | Hydrogen peroxide solution (30 per cent) | ARKEMA FRANCE Puteaux FR | 100049819;100096345 | CEP 2024-402 - Rev 00 | 2025/06/05 | Valid | 05/06/2030 | Chemical | 2025/06/05 | New application|CEP granted|05/06/2025 | |
1470 | Simeticone, SILFAR S 188 | WACKER CHEMIE AG Munich DE | 100020886;100093340 | CEP 2020-264 - Rev 01 | 2025/06/05 | Valid | Chemical | 2025/06/06 | Renewal|CEP granted|06/06/2025; Notification|Accepted - CEP remains valid|02/09/2021; New application|CEP granted|23/10/2020 |
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2372 | Esomeprazole magnesium trihydrate | NIFTY LABS PRIVATE LIMITED Hyderabad IN | 100014767;100042749 | CEP 2018-245 - Rev 04 | 2025/06/05 | Valid | Chemical | 2025/06/05 | Administrative procedure|CEP granted|05/06/2025; Renewal|CEP granted|23/05/2025; Minor revision|CEP granted|12/12/2023; Notification|CEP granted|16/08/2022 |
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2630 | Rivastigmine hydrogen tartrate | SHODHANA LABORATORIES PRIVATE LIMITED Hyderabad IN | 100021550;100030244 | CEP 2019-066 - Rev 02 | 2025/06/05 | Valid | Chemical | 2025/06/05 | Renewal|CEP granted|05/06/2025; Minor revision|CEP granted|31/03/2021 |
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2617 | Aripiprazole, Form II | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2018-267 - Rev 03 | 2025/06/05 | Valid | Chemical | 2025/06/05 | Renewal|CEP granted|05/06/2025; Major revision|CEP granted|17/02/2023; Notification|CEP granted|23/09/2021; Monograph revision|Accepted - CEP remains valid|13/04/2021 |
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454 | Acetazolamide, Process B | NAKODA CHEMICALS LIMITED Hyderabad IN | 100018043;100026836 | CEP 2010-352 - Rev 02 | 2025/06/04 | Valid | Chemical | 2025/06/04 | Minor revision|CEP granted|04/06/2025; Minor revision|Accepted - CEP remains valid|16/06/2023; Notification|CEP granted|13/05/2022 |
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2776 | Nicardipine hydrochloride | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | CEP 2024-005 - Rev 00 | 2025/06/04 | Valid | 04/06/2030 | Chemical | 2025/06/04 | New application|CEP granted|04/06/2025 |