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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2019 | Perindopril tert-butylamine, PER55LP | APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN | R0-CEP 2019-196 - Rev 01 | 2023/08/21 | Valid | 31/01/2025 | Chemical | 2023/08/21 | Minor revision|CEP granted|21/08/2023 | ||
2932 | Rivaroxaban | DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR | R0-CEP 2021-211 - Rev 00 | 2023/08/21 | Valid | 21/08/2028 | Chemical | 2023/08/21 | New application|CEP granted|21/08/2023 | ||
2624 | Meldonium dihydrate | SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN | R0-CEP 2022-113 - Rev 00 | 2023/08/21 | Valid | 21/08/2028 | Chemical | 2023/08/21 | New application|CEP granted|21/08/2023 | ||
582 | Clindamycin hydrochloride | XINYU PHARMACEUTICAL CO., LTD. Suzhou City CN | R0-CEP 2022-223 - Rev 00 | 2023/08/21 | Valid | 21/08/2028 | Chemical | 2023/08/21 | New application|CEP granted|21/08/2023 | ||
1792 | Nicotine resinate, Nicotine Content 18% with Glycerol 9.0-11.0% | NICOBRAND LIMITED Coleraine GB | R0-CEP 2022-477 - Rev 00 | 2023/08/21 | Valid | 21/08/2028 | Chemical | 2023/08/21 | New application|CEP granted|21/08/2023 | ||
1755 | Ketorolac trometamol | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | R1-CEP 2008-069 - Rev 05 | 2023/08/21 | Valid | Chemical | 2023/08/21 | Minor revision|CEP granted|21/08/2023; Major revision|CEP granted|21/06/2021; Minor revision|CEP granted|06/01/2021 |
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2019 | Perindopril tert-butylamine | APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN | R1-CEP 2010-332 - Rev 03 | 2023/08/21 | Valid | Chemical | 2023/08/21 | Minor revision|CEP granted|21/08/2023; Monograph revision|Accepted - CEP remains valid|08/04/2020 |
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2443 | Fulvestrant | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | R1-CEP 2013-255 - Rev 02 | 2023/08/21 | Valid | Chemical | 2023/08/21 | Minor revision|CEP granted|21/08/2023; Notification|CEP granted|10/11/2021 |
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1796 | Sucralfate | ZHEJIANG HAISEN PHARMACEUTICAL CO., LTD. Xiangtan Village CN | R0-CEP 2019-185 - Rev 01 | 2023/08/18 | Valid | 14/01/2026 | Chemical | 2023/08/18 | Minor revision|CEP granted|18/08/2023 | ||
1722 | Flunarizine dihydrochloride | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | R0-CEP 2020-224 - Rev 03 | 2023/08/18 | Valid | 01/02/2027 | Chemical | 2023/08/18 | Monograph revision|CEP granted|18/08/2023; Notification|CEP granted|03/02/2023; Minor revision|CEP granted|06/07/2022; New application|CEP granted|01/02/2022 |
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2154 | Telmisartan | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | R1-CEP 2010-301 - Rev 04 | 2023/08/18 | Valid | Chemical | 2023/08/18 | Notification|CEP granted|18/08/2023; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|24/06/2020 |
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2423 | Valsartan | MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN | R0-CEP 2018-275 - Rev 03 | 2023/08/17 | Valid | 09/10/2024 | Chemical | 2023/08/24 | Minor revision|CEP granted|24/08/2023; Minor revision|CEP granted|18/11/2022; Minor revision|CEP granted|24/09/2021 |
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2374 | Omeprazole magnesium | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | R0-CEP 2022-115 - Rev 00 | 2023/08/17 | Valid | 17/08/2028 | Chemical | 2023/08/17 | New application|CEP granted|17/08/2023 | ||
2191 | Atorvastatin calcium, Site 2 | ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN | R0-CEP 2023-160 - Rev 00 | 2023/08/17 | Valid | 17/08/2028 | Chemical | 2023/08/17 | New application|CEP granted|17/08/2023 | ||
654 | Beclometasone dipropionate, Micronised, non micronised | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | R1-CEP 2003-254 - Rev 06 | 2023/08/17 | Valid | Chemical | 2023/08/17 | Notification|CEP granted|17/08/2023; Notification|CEP granted|04/01/2022; Minor revision|CEP granted|22/01/2021 |
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1292 | Amphotericin B | North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN | R1-CEP 2005-212 - Rev 04 | 2023/08/17 | Valid | Chemical | 2024/07/31 | Minor revision|Accepted - CEP remains valid|31/07/2024; Notification|Rejected|28/05/2024; Minor revision|CEP granted|17/08/2023; Minor revision|Abandoned|07/06/2023; Notification|CEP granted|10/11/2020; Notification|Abandoned|18/09/2020 |
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2606 | Tadalafil | RAKSHIT PHARMACEUTICALS LIMITED Anakapalli IN | R1-CEP 2016-317 - Rev 00 | 2023/08/17 | Valid | Chemical | 2023/08/17 | Renewal|CEP granted|17/08/2023; Notification|CEP granted|11/01/2023; Minor revision|Accepted - CEP remains valid|13/04/2021 |
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2593 | Docetaxel, Code SPT1298 | SCINOPHARM TAIWAN, LTD. Shan-Hua TW | R1-CEP 2016-339 - Rev 00 | 2023/08/17 | Valid | Chemical | 2023/08/17 | Renewal|CEP granted|17/08/2023 | |||
1783 | Glycopyrronium bromide, Micronised, non-micronised | Inke, S.A. Castellbisbal ES | R1-CEP 2017-182 - Rev 00 | 2023/08/17 | Valid | Chemical | 2023/08/24 | Renewal|CEP granted|24/08/2023; Minor revision|Accepted - CEP remains valid|02/08/2022; Minor revision|CEP granted|02/03/2021; Minor revision|CEP granted|18/05/2020 |
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1187 | Carmustine | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2017-231 - Rev 03 | 2023/08/16 | Valid | 21/06/2024 | Chemical | 2023/08/16 | Notification|CEP granted|16/08/2023 |