| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1680 | Pyrantel embonate | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2005-294 - Rev 03 | 2025/02/25 | Valid | Chemical | 2025/02/25 | Minor revision|CEP granted|25/02/2025; Notification|Accepted - CEP remains valid|23/06/2023; Minor revision|CEP granted|15/12/2020; Monograph revision|Accepted - CEP remains valid|28/04/2020 |
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| 2780 | Temozolomide, Form-III | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2017-270 - Rev 02 | 2025/02/25 | Valid | Chemical | 2025/02/25 | Minor revision|CEP granted|25/02/2025; Renewal|CEP granted|16/01/2024 |
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| 2373 | Meloxicam | ARCH PHARMALABS LIMITED Mumbai IN | 100011823;100095249 | CEP 2019-283 - Rev 03 | 2025/02/25 | Valid | 02/09/2027 | Chemical | 2025/02/25 | Notification|CEP granted|25/02/2025; Minor revision|CEP granted|05/01/2024; Notification|CEP granted|04/12/2023; Minor revision|Accepted - CEP remains valid|24/10/2022 |
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| 1794 | Paclitaxel, Produced by a semi-synthetic process – Process II | INDENA S.P.A. Milan IT | 100006081;100011479 | CEP 2019-346 - Rev 06 | 2025/02/25 | Valid | Chemical | 2025/02/25 | Renewal|CEP granted|25/02/2025; Minor revision|CEP granted|11/07/2023; Notification|CEP granted|05/10/2022; Minor revision|CEP granted|05/09/2022; Notification|Accepted - CEP remains valid|29/09/2021; Minor revision|CEP granted|23/02/2021; Notification|CEP granted|25/08/2020 |
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| 2020 | Rilmenidine dihydrogen phosphate | ORIL INDUSTRIE Bolbec FR | 100012082;100022735 | CEP 2015-244 - Rev 01 | 2025/02/24 | Valid | Chemical | 2025/02/24 | Minor revision|CEP granted|24/02/2025; Minor revision|Accepted - CEP remains valid|23/04/2024; Renewal|CEP granted|29/10/2021 |
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| 1722 | Flunarizine dihydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2004-264 - Rev 06 | 2025/02/24 | Valid | Chemical | 2025/02/24 | Minor revision|CEP granted|24/02/2025; Monograph revision|CEP granted|04/08/2023; Minor revision|Accepted - CEP remains valid|01/08/2022; Minor revision|CEP granted|07/01/2021 |
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| 693 | Tretinoin | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 1998-082 - Rev 08 | 2025/02/24 | Valid | Chemical | 2025/02/24 | Minor revision|CEP granted|24/02/2025; Notification|Accepted - CEP remains valid|09/08/2022; Minor revision|CEP granted|18/06/2021 |
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| 1718 | Diclazuril for veterinary use | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN | 100022562;100031241 | CEP 2018-234 - Rev 04 | 2025/02/24 | Valid | Chemical | 2025/02/24 | Renewal|CEP granted|24/02/2025; Notification|Accepted - CEP remains valid|05/06/2024; Major revision|CEP granted|27/04/2023; Monograph revision|CEP granted|10/01/2023; Minor revision|CEP granted|07/04/2021 |
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| . | Foetal Bovine Serum | LIFE TECHNOLOGIES CORPORATION Carlsbad US | 100050231;100093064 | CEP 2000-089 - Rev 04 | 2025/02/24 | Valid | TSE | 2025/02/24 | Major revision|CEP granted|24/02/2025 | ||
| 2896 | Thiocolchicoside crystallised from ethanol | SARV BIO LABS PRIVATE LIMITED Sirmaur IN | 100039294;100061855 | CEP 2022-239 - Rev 00 | 2025/02/24 | Valid | 24/02/2030 | Chemical | 2025/02/24 | New application|CEP granted|24/02/2025 | |
| 2887 | Raltegravir potassium | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | CEP 2023-211 - Rev 00 | 2025/02/24 | Valid | 24/02/2030 | Chemical | 2025/02/24 | New application|CEP granted|24/02/2025 | |
| 1335 | Itraconazole | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2020-265 - Rev 03 | 2025/02/24 | Valid | 21/03/2027 | Chemical | 2025/02/24 | Minor revision|CEP granted|24/02/2025; Minor revision|Accepted - CEP remains valid|29/11/2023; Notification|Rejected|28/09/2023; Notification|CEP granted|03/02/2023; Minor revision|CEP granted|01/07/2022; New application|CEP granted|21/03/2022 |
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| 50 | Procaine Hydrochloride | FLARER S.A. Balerna CH | 100047920;100079248 | CEP 2021-223 - Rev 02 | 2025/02/24 | Valid | 14/11/2027 | Chemical | 2025/12/03 | Minor revision|Accepted - CEP remains valid|03/12/2025; Minor revision|CEP granted|24/02/2025; Minor revision|CEP granted|02/02/2024; New application|CEP granted|14/11/2022 |
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| 2593 | Docetaxel, Process-2 | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | CEP 2012-287 - Rev 02 | 2025/02/21 | Valid | Chemical | 2025/02/21 | Minor revision|CEP granted|21/02/2025; Minor revision|CEP granted|20/01/2023 |
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| 1286 | Alfacalcidol | CARBOGEN AMCIS B.V. Veenendaal NL | 100002010;100009870 | CEP 1998-097 - Rev 12 | 2025/02/21 | Valid | Chemical and TSE | 2025/02/21 | Administrative procedure|CEP granted|21/02/2025; Administrative procedure|CEP granted|04/02/2025; Minor revision|CEP granted|23/01/2025; Notification|CEP granted|15/03/2023; Notification|CEP granted|09/03/2022 |
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| 2296 | Pantoprazole sodium sesquihydrate | MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN | 100018316;100070723 | CEP 2019-274 - Rev 01 | 2025/02/21 | Valid | Chemical | 2025/02/21 | Renewal|CEP granted|21/02/2025 | ||
| 2019 | Perindopril tert-butylamine | ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN | 100022703;100031392 | CEP 2023-355 - Rev 01 | 2025/02/21 | Valid | 21/01/2030 | Chemical | 2025/02/21 | Notification|CEP granted|21/02/2025; New application|CEP granted|21/01/2025 |
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| 1472 | Sodium hyaluronate, Intrinsic viscosity 2.3 m3/kg, by fermentation, for parenteral administration other than intra-articular administration and intra-ocular use | SHANDONG FOCUSFREDA BIOTECH CO., LTD. Qufu CN | 100053560;100094671 | CEP 2021-388 - Rev 01 | 2025/02/20 | Valid | 07/06/2028 | Chemical | 2025/02/20 | Minor revision|CEP granted|20/02/2025; New application|CEP granted|07/06/2023 |
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| 2064 | Chondroitin sulfate sodium, Terrestrial origin | ZPD A/S Esbjerg DK | 100023030;100031772 | CEP 2022-508 - Rev 01 | 2025/02/20 | Valid | 23/05/2029 | Chemical and TSE | 2025/02/20 | Major revision|CEP granted|20/02/2025; New application|CEP granted|23/05/2024 |
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| 1035 | Phenylephrine | MALLADI DRUGS AND PHARMACEUTICALS LIMITED Ranipet IN | 100017917;100027111 | CEP 2018-142 - Rev 03 | 2025/02/20 | Valid | Chemical | 2025/02/20 | Renewal|CEP granted|20/02/2025; Notification|CEP granted|13/09/2021; Minor revision|CEP granted|09/04/2020 |
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