| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 14 | Calcium carbonate | SUDEEP PHARMA LIMITED Vadodara IN | 100033274;100051937 | CEP 2013-299 - Rev 03 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Notification|CEP granted|11/03/2025; Minor revision|CEP granted|31/08/2022 |
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| 1653 | Potassium clavulanate, diluted, With microcrystalline cellulose in the ratio 1:1 | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN | 100025540;100034769 | CEP 2011-375 - Rev 03 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Notification|CEP granted|11/03/2025; Minor revision|Accepted - CEP remains valid|29/02/2024; Minor revision|Accepted - CEP remains valid|04/10/2022; Minor revision|CEP granted|08/04/2021; Minor revision|Accepted - CEP remains valid|20/02/2020 |
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| 2244 | Tacrolimus monohydrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2018-233 - Rev 06 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Administrative procedure|CEP granted|11/03/2025; Notification|CEP granted|04/03/2025; Renewal|CEP granted|05/08/2024; Minor revision|Accepted - CEP remains valid|17/11/2023; Minor revision|CEP granted|25/11/2022; Major revision|CEP granted|06/04/2022; Minor revision|Rejected|04/11/2021; Minor revision|CEP granted|01/09/2020 |
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| 14 | Calcium carbonate, Granular | SUDEEP PHARMA LIMITED Vadodara IN | 100033274;100051937 | CEP 2020-379 - Rev 02 | 2025/03/11 | Valid | 21/04/2026 | Chemical | 2025/03/11 | Notification|CEP granted|11/03/2025; Minor revision|CEP granted|02/09/2022; New application|CEP granted|21/04/2021 |
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| 475 | Chlorpromazine hydrochloride | MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN | 100013041;100021615 | CEP 2021-018 - Rev 03 | 2025/03/11 | Valid | 01/08/2027 | Chemical | 2025/03/11 | Minor revision|CEP granted|11/03/2025; Notification|CEP granted|15/02/2023; Administrative procedure|CEP granted|30/08/2022; New application|CEP granted|01/08/2022 |
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| 3036 | Teriflunomide | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2023-135 - Rev 01 | 2025/03/11 | Valid | 25/07/2029 | Chemical | 2025/03/11 | Minor revision|CEP granted|11/03/2025; New application|CEP granted|26/07/2024 |
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| 2335 | Ropivacaine hydrochloride monohydrate | EDMOND PHARMA S.R.L. Paderno Dugnano IT | 100000246;100002746 | CEP 2007-342 - Rev 04 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Notification|CEP granted|11/03/2025; Minor revision|Accepted - CEP remains valid|31/07/2023; Notification|Rejected|15/05/2023; Minor revision|CEP granted|15/07/2021 |
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| 1673 | Isoflurane | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN | 100025540;100034769 | CEP 2010-078 - Rev 01 | 2025/03/11 | Valid | Chemical | 2025/03/24 | Minor revision|Accepted - CEP remains valid|24/03/2025; Notification|CEP granted|11/03/2025; Minor revision|Accepted - CEP remains valid|04/09/2020 |
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| 1275 | Ursodeoxycholic acid | ARCH PHARMALABS LIMITED Mumbai IN | 100011823;100095249 | CEP 2019-029 - Rev 06 | 2025/03/11 | Valid | Chemical and TSE | 2025/10/15 | Renewal|Accepted - CEP remains valid|15/10/2025; Notification|CEP granted|11/03/2025; Minor revision|CEP granted|17/06/2024; Minor revision|CEP granted|07/02/2024; Notification|CEP granted|04/12/2023; Minor revision|CEP granted|23/08/2023; Minor revision|CEP granted|19/12/2022 |
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| 1373 | Testosterone | SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN | 100048889;100089578 | CEP 2023-267 - Rev 00 | 2025/03/11 | Valid | 11/03/2030 | Chemical | 2025/03/11 | New application|CEP granted|11/03/2025 | |
| 673 | Medroxyprogesterone acetate, Crystalline | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-153 - Rev 05 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Notification|CEP granted|23/11/2021; Minor revision|CEP granted|11/03/2021; Notification|CEP granted|07/08/2020 |
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| 611 | Fluorouracil | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2005-113 - Rev 06 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Minor revision|Accepted - CEP remains valid|04/03/2024; Minor revision|Abandoned|13/09/2023; Notification|CEP granted|22/11/2021; Minor revision|CEP granted|13/04/2021 |
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| 673 | Medroxyprogesterone acetate, Micronised (M1, M2, M3) | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2000-276 - Rev 06 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Notification|CEP granted|23/11/2021; Minor revision|CEP granted|13/04/2021 |
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| 599 | Cisplatin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2000-411 - Rev 04 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Monograph revision|CEP granted|18/10/2022 |
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| 2017 | Oxaliplatin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2005-259 - Rev 04 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Notification|CEP granted|22/11/2021; Minor revision|CEP granted|29/01/2021 |
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| 1225 | Hydroxyethyl salicylate | UBE CORP. Ube JP | 100012830;100068667 | CEP 2014-078 - Rev 02 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Notification|Accepted - CEP remains valid|29/01/2024; Monograph revision|CEP granted|04/04/2023; Renewal|CEP granted|15/03/2022 |
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| 2019 | Perindopril tert-butylamine | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2010-118 - Rev 05 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Minor revision|Accepted - CEP remains valid|05/04/2024; Minor revision|Accepted - CEP remains valid|27/03/2023; Minor revision|CEP granted|27/07/2021; Minor revision|Accepted - CEP remains valid|09/11/2020; Monograph revision|Accepted - CEP remains valid|10/06/2020 |
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| 1449 | Mometasone furoate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2009-198 - Rev 04 | 2025/03/10 | Valid | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Minor revision|CEP granted|06/04/2023; Notification|CEP granted|17/02/2022 |
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| 1764 | Rocuronium bromide | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-023 - Rev 06 | 2025/03/10 | Valid | Chemical | 2025/10/17 | Minor revision|Accepted - CEP remains valid|17/10/2025; Notification|CEP granted|10/03/2025; Minor revision|CEP granted|21/08/2024; Minor revision|CEP granted|25/07/2022; Notification|CEP granted|22/11/2021 |
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| 429 | Progesterone, Micronised | LA CHANDRA PHARMALAB PRIVATE LIMITED Ahmedabad IN | 100048266;100079876 | CEP 2023-385 - Rev 00 | 2025/03/10 | Valid | 10/03/2030 | Chemical | 2025/03/10 | New application|CEP granted|10/03/2025 |
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