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 |
---|---|---|---|---|---|---|---|---|---|---|---|
394 | Hydrochlorothiazide, Process I | IPCA LABORATORIES LIMITED Mumbai IN | R1-CEP 2004-013 - Rev 06 | 2023/08/29 | Valid | Chemical | 2023/08/29 | Minor revision|CEP granted|29/08/2023; Major revision|CEP granted|06/12/2022; Minor revision|CEP granted|27/07/2020 |
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394 | Hydrochlorothiazide | CTX LIFESCIENCES PVT. LIMITED Surat IN | R1-CEP 2008-021 - Rev 05 | 2023/08/29 | Valid | Chemical | 2023/08/29 | Minor revision|CEP granted|29/08/2023; Minor revision|CEP granted|05/04/2023; Minor revision|CEP granted|11/01/2022 |
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1619 | Magnesium pidolate | Global Calcium Private Limited Hosur IN | R1-CEP 2016-064 - Rev 01 | 2023/08/29 | Valid | Chemical | 2023/08/29 | Notification|CEP granted|29/08/2023; Renewal|CEP granted|10/10/2022 |
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2230 | Latanoprost | CAYMAN CHEMICAL COMPANY, INC. Ann Arbor US | R0-CEP 2022-093 - Rev 00 | 2023/08/28 | Valid | 28/08/2028 | Chemical | 2024/05/13 | Notification|Accepted - CEP remains valid|13/05/2024; Minor revision|Accepted - CEP remains valid|09/11/2023; New application|CEP granted|28/08/2023 |
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2335 | Ropivacaine hydrochloride monohydrate | Chemwerth, Inc. Woodbridge US | R0-CEP 2022-198 - Rev 00 | 2023/08/28 | Valid | 28/08/2028 | Chemical | 2023/08/28 | New application|CEP granted|28/08/2023 | ||
892 | Crospovidone, Type A and B | BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN | R0-CEP 2023-020 - Rev 00 | 2023/08/28 | Valid | 28/08/2028 | Chemical | 2023/08/28 | New application|CEP granted|28/08/2023 | ||
2857 | Trazodone hydrochloride, Process II | AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. Rome IT | R0-CEP 2023-098 - Rev 00 | 2023/08/28 | Valid | 28/08/2028 | Chemical | 2024/03/20 | Notification|Accepted - CEP remains valid|20/03/2024; New application|CEP granted|28/08/2023 |
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2779 | Solifenacin succinate | DELMAR CHEMICALS INC. LaSalle CA | R1-CEP 2016-302 - Rev 00 | 2023/08/28 | Valid | Chemical | 2023/08/28 | Renewal|CEP granted|28/08/2023 | |||
1745 | Carvedilol, Synthetic route B | EGIS Pharmaceuticals PLC Budapest HU | R1-CEP 2016-314 - Rev 00 | 2023/08/28 | Valid | Chemical | 2023/08/28 | Renewal|CEP granted|28/08/2023; Major revision|CEP granted|02/08/2022; Minor revision|CEP granted|26/08/2020 |
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1558 | Propofol | EMCURE PHARMACEUTICALS LIMITED Pune IN | R0-CEP 2020-203 - Rev 01 | 2023/08/25 | Valid | 05/01/2026 | Chemical | 2023/08/25 | Notification|CEP granted|25/08/2023; Major revision|Rejected|09/05/2023; New application|CEP granted|05/01/2021 |
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2898 | Atazanavir sulfate | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LTD. Laogang Town CN | R0-CEP 2021-115 - Rev 00 | 2023/08/25 | Valid | 25/08/2028 | Chemical | 2023/08/25 | New application|CEP granted|25/08/2023 | ||
2778 | Sitagliptin phosphate monohydrate | CHEMO SMS ENTERPRISE, SL Madrid ES | R0-CEP 2021-295 - Rev 00 | 2023/08/25 | Valid | 25/08/2028 | Chemical | 2023/08/25 | New application|CEP granted|25/08/2023 | ||
1173 | Benserazide hydrochloride | Deva Holding A.Ş. Istanbul TR | R0-CEP 2021-345 - Rev 00 | 2023/08/25 | Valid | 25/08/2028 | Chemical | 2023/08/25 | New application|CEP granted|25/08/2023 | ||
3014 | Rotigotine | CHENGDU EASTON BIOPHARMACEUTICALS CO., LTD. Chengdu CN | R0-CEP 2022-035 - Rev 00 | 2023/08/25 | Valid | 25/08/2028 | Chemical | 2023/08/25 | New application|CEP granted|25/08/2023 | ||
1049 | Threonine | AMINO GMBH Frellstedt DE | R1-CEP 2004-277 - Rev 03 | 2023/08/25 | Valid | Chemical | 2023/08/25 | Notification|CEP granted|25/08/2023; Notification|Accepted - CEP remains valid|24/11/2022; Minor revision|CEP granted|22/06/2020 |
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1705 | Sertraline hydrochloride, Form-I | HETERO DRUGS LIMITED Hyderabad IN | R1-CEP 2012-292 - Rev 02 | 2023/08/25 | Valid | Chemical | 2023/08/25 | Major revision|CEP granted|25/08/2023; Minor revision|Accepted - CEP remains valid|09/04/2020 |
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2114 | Lysine acetate | AMINO GMBH Frellstedt DE | R1-CEP 2016-042 - Rev 01 | 2023/08/25 | Valid | Chemical | 2023/08/25 | Monograph revision|CEP granted|25/08/2023; Renewal|CEP granted|15/07/2022 |
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1322 | Fenofibrate | D.K. PHARMACHEM PVT. LTD. Badlapur IN | R0-CEP 2020-213 - Rev 00 | 2023/08/24 | Valid | 24/08/2028 | Chemical | 2023/08/24 | New application|CEP granted|24/08/2023 | ||
1075 | Budesonide, Process II, micronised | CIPLA LIMITED Mumbai IN | R0-CEP 2023-094 - Rev 00 | 2023/08/24 | Valid | 24/08/2028 | Chemical | 2023/08/24 | New application|CEP granted|24/08/2023 | ||
1181 | Buprenorphine hydrochloride, Process II | SPECGX LLC Webster Groves US | R0-CEP 2023-107 - Rev 00 | 2023/08/24 | Valid | 24/08/2028 | Chemical | 2023/08/24 | New application|CEP granted|24/08/2023 |