| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2191 | Atorvastatin calcium, IM2 process | ZHEJIANG JIANGBEI PHARMACEUTICAL CO., LTD. Taizhou City CN | R0-CEP 2021-383 - Rev 01 | 2023/08/31 | Valid | 18/03/2027 | Chemical | 2023/08/31 | Major revision|CEP granted|31/08/2023; New application|CEP granted|18/03/2022 |
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| 3036 | Teriflunomide | SABA ILAC SANAYII VE TICARET A.S. Istanbul TR | R0-CEP 2021-417 - Rev 00 | 2023/08/31 | Valid | 31/08/2028 | Chemical | 2023/08/31 | New application|CEP granted|31/08/2023 | ||
| 1251 | Oxybuprocaine hydrochloride | SIEGFRIED EVIONNAZ SA Evionnaz CH | R0-CEP 2022-104 - Rev 00 | 2023/08/31 | Valid | 31/08/2028 | Chemical | 2023/08/31 | New application|CEP granted|31/08/2023 | ||
| 1705 | Sertraline hydrochloride | VERDANT LIFE SCIENCES PVT., LIMITED Visakhapatnam IN | R0-CEP 2022-191 - Rev 00 | 2023/08/31 | Valid | 31/08/2028 | Chemical | 2023/08/31 | New application|CEP granted|31/08/2023 | ||
| 1414 | Detomidine hydrochloride for veterinary use | FINORTEX, S.L. Sant Llorenç d’Hortons ES | R0-CEP 2022-324 - Rev 00 | 2023/08/31 | Valid | 31/08/2028 | Chemical | 2023/08/31 | New application|CEP granted|31/08/2023 | ||
| 1240 | Mefenamic acid | BEIJING JINCHENG TAIER PHARMACEUTICAL CO., LTD. Beiwu Town CN | R0-CEP 2022-372 - Rev 00 | 2023/08/31 | Valid | 31/08/2028 | Chemical | 2023/08/31 | New application|CEP granted|31/08/2023 | ||
| 542 | Busulfan | EMCURE PHARMACEUTICALS LIMITED Pune IN | R1-CEP 2013-341 - Rev 01 | 2023/08/31 | Valid | Chemical | 2023/08/31 | Notification|CEP granted|31/08/2023; Renewal|CEP granted|23/02/2021 |
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| 568 | Propranolol hydrochloride | MANKIND PHARMA LIMITED New Delhi IN | R0-CEP 2021-104 - Rev 00 | 2023/08/30 | Valid | 30/08/2028 | Chemical | 2023/08/30 | New application|CEP granted|30/08/2023 | ||
| 2606 | Tadalafil | ASSURGEN PHARMA PVT LTD Lalamkoduru Village IN | R0-CEP 2021-498 - Rev 00 | 2023/08/30 | Valid | 30/08/2028 | Chemical | 2023/08/30 | New application|CEP granted|30/08/2023 | ||
| 2598 | Levofloxacin hemihydrate | ZHEJIANG STARRY PHARMACEUTICAL CO., LTD. Xianju CN | R0-CEP 2022-059 - Rev 00 | 2023/08/30 | Valid | 30/08/2028 | Chemical | 2023/08/30 | New application|CEP granted|30/08/2023 | ||
| 1012 | Famotidine | ORCHEV PHARMA PRIVATE LIMITED Rajkot IN | R0-CEP 2022-307 - Rev 00 | 2023/08/30 | Valid | 30/08/2028 | Chemical | 2023/08/30 | New application|CEP granted|30/08/2023 | ||
| 891 | Copovidone, K-value: 25.2-30.8 | BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN | R0-CEP 2023-019 - Rev 00 | 2023/08/30 | Valid | 30/08/2028 | Chemical | 2023/08/30 | New application|CEP granted|30/08/2023 | ||
| 1103 | Fentanyl citrate | VERANOVA, L.P. West Deptford US | R1-CEP 2005-104 - Rev 04 | 2023/08/30 | Valid | Chemical | 2023/08/30 | Notification|CEP granted|30/08/2023; Minor revision|CEP granted|28/01/2022 |
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| 755 | Carbidopa, Micronised, non-micronised | Zhejiang Chiral Medicine Chemicals Co., Ltd. Hangzhou CN | R1-CEP 2007-067 - Rev 06 | 2023/08/30 | Valid | Chemical | 2024/04/16 | Minor revision|Accepted - CEP remains valid|16/04/2024; Notification|CEP granted|30/08/2023; Administrative procedure|CEP granted|19/08/2022; Minor revision|CEP granted|10/08/2022; Minor revision|Accepted - CEP remains valid|15/10/2021; Minor revision|Accepted - CEP remains valid|08/09/2020 |
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| 1062 | Alfentanil hydrochloride hydrate | VERANOVA, L.P. West Deptford US | R1-CEP 2011-195 - Rev 02 | 2023/08/30 | Valid | Chemical | 2024/04/24 | Minor revision|Accepted - CEP remains valid|24/04/2024; Notification|CEP granted|30/08/2023; Minor revision|CEP granted|14/02/2022 |
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| 755 | Carbidopa, Process B, micronised, non-micronised | Zhejiang Chiral Medicine Chemicals Co., Ltd. Hangzhou CN | R1-CEP 2014-126 - Rev 01 | 2023/08/30 | Valid | Chemical | 2023/08/30 | Notification|CEP granted|30/08/2023; Minor revision|Accepted - CEP remains valid|08/08/2022; Minor revision|Accepted - CEP remains valid|15/10/2021; Minor revision|Accepted - CEP remains valid|08/09/2020 |
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| 546 | Chlortalidone | MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN | R0-CEP 2018-186 - Rev 01 | 2023/08/29 | Valid | 21/06/2024 | Chemical | 2023/08/29 | Minor revision|CEP granted|29/08/2023; Monograph revision|Accepted - CEP remains valid|12/04/2022 |
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| 2254 | Moxifloxacin hydrochloride | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shangyu CN | R0-CEP 2020-316 - Rev 01 | 2023/08/29 | Valid | 21/09/2027 | Chemical | 2024/06/05 | Notification|Accepted - CEP remains valid|05/06/2024; Minor revision|CEP granted|29/08/2023; New application|CEP granted|21/09/2022 |
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| 1712 | Carboprost trometamol | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R0-CEP 2021-354 - Rev 00 | 2023/08/29 | Valid | 29/08/2028 | Chemical | 2023/08/29 | New application|CEP granted|29/08/2023 | ||
| 2288 | Citalopram hydrobromide | VIRUPAKSHA ORGANICS LIMITED Hyderabad IN | R0-CEP 2021-437 - Rev 00 | 2023/08/29 | Valid | 29/08/2028 | Chemical | 2023/08/30 | New application|CEP granted|30/08/2023 |
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