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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1575 | Tiapride hydrochloride, Process 2 | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2014-274 - Rev 01 | 2025/02/13 | Valid | Chemical | 2025/02/13 | Notification|CEP granted|13/02/2025; Minor revision|Accepted - CEP remains valid|28/05/2024; Minor revision|Accepted - CEP remains valid|13/02/2023 |
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1354 | Oxybutynin hydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2019-350 - Rev 01 | 2025/02/13 | Valid | 08/11/2027 | Chemical | 2025/02/13 | Notification|CEP granted|13/02/2025 | |
2531 | Clopidogrel hydrogen sulfate, Form-II, milled and non-milled | MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN | 100018316;100070723 | CEP 2019-318 - Rev 01 | 2025/02/13 | Valid | Chemical | 2025/02/13 | Renewal|CEP granted|13/02/2025 | ||
1524 | Gliclazide, AP | BAL PHARMA LIMITED Bengaluru IN | 100016398;100041736 | CEP 2013-039 - Rev 01 | 2025/02/13 | Valid | Chemical | 2025/02/13 | Minor revision|CEP granted|13/02/2025; Renewal|CEP granted|27/08/2020 |
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23 | Diphenhydramine hydrochloride | SUPRIYA LIFESCIENCE LIMITED Mumbai IN | 100015796;100024574 | CEP 2019-120 - Rev 01 | 2025/02/13 | Valid | 27/09/2027 | Chemical | 2025/02/13 | Minor revision|CEP granted|13/02/2025 | |
2736 | Imatinib mesilate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2015-096 - Rev 05 | 2025/02/13 | Valid | Chemical | 2025/02/13 | Administrative procedure|CEP granted|13/02/2025; Minor revision|CEP granted|03/01/2025; Notification|CEP granted|19/07/2023; Notification|Accepted - CEP remains valid|22/11/2022; Administrative procedure|CEP granted|02/12/2021; Notification|CEP granted|22/11/2021; Minor revision|Accepted - CEP remains valid|17/09/2021; Renewal|CEP granted|24/06/2021; Minor revision|Accepted - CEP remains valid|30/06/2020 |
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485 | Dihydrostreptomycin sulfate for veterinary use | North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN | 100021261;100029965 | CEP 2001-393 - Rev 07 | 2025/02/13 | Valid | Chemical | 2025/02/13 | Minor revision|CEP granted|13/02/2025; Minor revision|CEP granted|28/06/2023; Minor revision|Accepted - CEP remains valid|13/01/2021 |
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1272 | Tryptophan | Ajinomoto Co., Inc. Tokyo JP | 100011941;100021464 | CEP 1998-137 - Rev 07 | 2025/02/12 | Valid | Chemical | 2025/02/13 | Notification|CEP granted|13/02/2025; Notification|CEP granted|12/02/2024; Notification|CEP granted|31/03/2023 |
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1146 | Roxithromycin | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 1999-029 - Rev 10 | 2025/02/12 | Valid | Chemical | 2025/02/13 | Minor revision|CEP granted|13/02/2025; Minor revision|Accepted - CEP remains valid|23/11/2020 |
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1137 | Pentamidine diisetionate | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022690 | CEP 2022-169 - Rev 01 | 2025/02/12 | Valid | 10/03/2028 | Chemical | 2025/02/12 | Notification|CEP granted|12/02/2025; New application|CEP granted|10/03/2023 |
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2631 | Rosuvastatin calcium, AM code | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-400 - Rev 01 | 2025/02/12 | Valid | 14/01/2030 | Chemical | 2025/02/12 | Administrative procedure|CEP granted|12/02/2025; New application|CEP granted|14/01/2025 |
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1711 | Buspirone hydrochloride | MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN | 100013041;100021615 | CEP 2023-395 - Rev 00 | 2025/02/12 | Valid | 12/02/2030 | Chemical | 2025/02/12 | New application|CEP granted|12/02/2025 | |
1045 | Sulpiride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 1998-073 - Rev 10 | 2025/02/12 | Valid | Chemical | 2025/02/12 | Notification|CEP granted|12/02/2025; Minor revision|Accepted - CEP remains valid|28/06/2024; Minor revision|Accepted - CEP remains valid|26/08/2022; Minor revision|CEP granted|27/04/2021 |
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1564 | Sodium alendronate trihydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-048 - Rev 03 | 2025/02/12 | Valid | Chemical | 2025/02/12 | Minor revision|CEP granted|12/02/2025; Notification|CEP granted|11/01/2024; Minor revision|Accepted - CEP remains valid|31/07/2023; Minor revision|Accepted - CEP remains valid|25/05/2022 |
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330 | Gelatin, Acid bone gelatin | TESSENDERLO GROUP N.V. Vilvoorde BE | 100038809;100060926 | CEP 2008-187 - Rev 01 | 2025/02/12 | Valid | TSE | 2025/02/12 | Major revision|CEP granted|12/02/2025 | ||
3078 | Riociguat, Modification I, micronised | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2023-191 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 | |
2631 | Rosuvastatin calcium, ZH code | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-407 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 | |
1750 | Fluticasone propionate | CURIA SPAIN S.A.U. Boecillo ES | 100011649;100019586 | CEP 2013-315 - Rev 02 | 2025/02/11 | Valid | Chemical | 2025/02/11 | Minor revision|CEP granted|11/02/2025; Notification|CEP granted|25/08/2021; Monograph revision|Accepted - CEP remains valid|20/04/2021 |
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931 | Metformin Hydrochloride | ABHILASHA PHARMA PRIVATE LIMITED Ankleshwar IN | 100050097;100087479 | CEP 2024-016 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 | |
2637 | Pemetrexed disodium heptahydrate | SHIVALIK RASAYAN LIMITED Bharuch IN | 100048259;100079859 | CEP 2023-301 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 |