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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1724 | Formoterol fumarate dihydrate | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2006-227 - Rev 03 | 2025/06/24 | Valid | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025; Notification|Accepted - CEP remains valid|22/09/2023; Notification|CEP granted|28/07/2022; Monograph revision|Accepted - CEP remains valid|06/05/2022 |
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616 | Haloperidol | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2020-026 - Rev 03 | 2025/06/24 | Valid | 05/01/2027 | Chemical | 2025/06/24 | Administrative procedure|CEP granted|24/06/2025; Notification|CEP granted|06/06/2025; Major revision|CEP granted|22/02/2024; New application|CEP granted|05/01/2022 |
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559 | Mannitol, For use in the manufacture of parenteral preparations | CARGILL S.R.L. Castelmassa IT | 100049176;100083235 | CEP 2005-019 - Rev 03 | 2025/06/24 | Valid | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025 | ||
2002 | Proguanil hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2011-182 - Rev 01 | 2025/06/24 | Valid | Chemical | 2025/06/24 | Minor revision|CEP granted|24/06/2025; Notification|Accepted - CEP remains valid|08/01/2024; Minor revision|Accepted - CEP remains valid|19/04/2022; Notification|Accepted - CEP remains valid|15/01/2021 |
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1765 | Salmeterol xinafoate, Non-micronised and micronised | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2006-226 - Rev 04 | 2025/06/24 | Valid | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025; Minor revision|CEP granted|05/03/2024; Notification|CEP granted|28/07/2022 |
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1794 | Paclitaxel, Produced by semi-synthetic process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2009-236 - Rev 06 | 2025/06/24 | Valid | Chemical | 2025/06/24 | Minor revision|CEP granted|24/06/2025; Major revision|CEP granted|25/11/2024; Minor revision|CEP granted|27/02/2024; Minor revision|CEP granted|19/11/2021 |
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616 | Haloperidol | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2020-149 - Rev 01 | 2025/06/24 | Valid | 04/04/2028 | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025; Minor revision|Accepted - CEP remains valid|20/08/2024; Minor revision|Accepted - CEP remains valid|09/01/2024; Notification|Rejected|26/09/2023; New application|CEP granted|04/04/2023 |
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1409 | Clenbuterol Hydrochloride | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2020-172 - Rev 02 | 2025/06/24 | Valid | 30/03/2027 | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025; Notification|Accepted - CEP remains valid|21/09/2023; Notification|CEP granted|28/07/2022; New application|CEP granted|30/03/2022 |
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1431 | Haloperidol decanoate | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2020-080 - Rev 03 | 2025/06/24 | Valid | 20/05/2027 | Chemical | 2025/06/24 | Administrative procedure|CEP granted|24/06/2025; Notification|CEP granted|06/06/2025; Minor revision|Accepted - CEP remains valid|08/11/2024; Major revision|CEP granted|30/08/2024; New application|CEP granted|20/05/2022 |
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901 | Fenoterol hydrobromide | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2020-160 - Rev 03 | 2025/06/24 | Valid | 08/03/2027 | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025; Minor revision|CEP granted|14/11/2023; Notification|Rejected|21/09/2023; Notification|CEP granted|28/07/2022; New application|CEP granted|08/03/2022 |
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1750 | Fluticasone propionate, Micronised | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2020-078 - Rev 03 | 2025/06/24 | Valid | 29/10/2026 | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025; Minor revision|CEP granted|11/12/2023; Notification|CEP granted|28/07/2022; New application|CEP granted|29/10/2021 |
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2191 | Atorvastatin calcium, Trihydrate | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2022-262 - Rev 02 | 2025/06/24 | Valid | 16/02/2029 | Chemical | 2025/06/24 | Administrative procedure|CEP granted|24/06/2025; Notification|CEP granted|06/06/2025; New application|CEP granted|16/02/2024 |
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2931 | Sorafenib tosilate, Form-I | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2023-185 - Rev 01 | 2025/06/24 | Valid | 29/10/2029 | Chemical | 2025/06/24 | Monograph revision|CEP granted|24/06/2025; New application|CEP granted|29/10/2024 |
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919 | Ipratropium bromide, Micronised | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2023-137 - Rev 01 | 2025/06/24 | Valid | 05/11/2029 | Chemical | 2025/06/24 | Notification|CEP granted|24/06/2025; New application|CEP granted|05/11/2024 |
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1250 | Omega-3-acid ethyl esters 90, Code K85EE - containing alpha tocopherol as antioxidant | BASF AS Oslo NO | 100003052;100032709 | CEP 2008-132 - Rev 05 | 2025/06/23 | Valid | Chemical | 2025/06/23 | Minor revision|CEP granted|23/06/2025; Notification|Accepted - CEP remains valid|25/07/2023; Notification|CEP granted|21/01/2020 |
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2541 | Quetiapine Fumarate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2017-210 - Rev 05 | 2025/06/23 | Valid | Chemical | 2025/06/23 | Minor revision|CEP granted|23/06/2025; Renewal|CEP granted|17/04/2024; Minor revision|CEP granted|19/12/2023; Minor revision|CEP granted|15/11/2022; Minor revision|CEP granted|10/01/2022; Minor revision|Accepted - CEP remains valid|06/11/2020 |
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2779 | Solifenacin succinate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2016-059 - Rev 02 | 2025/06/23 | Valid | Chemical | 2025/06/23 | Minor revision|CEP granted|23/06/2025; Notification|CEP granted|16/01/2024; Renewal|CEP granted|27/09/2022 |
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1524 | Gliclazide, AP | BAL PHARMA LIMITED Bengaluru IN | 100016398;100041736 | CEP 2013-039 - Rev 03 | 2025/06/23 | Valid | Chemical | 2025/06/23 | Notification|CEP granted|23/06/2025; Administrative procedure|CEP granted|03/03/2025; Minor revision|CEP granted|13/02/2025; Renewal|CEP granted|27/08/2020 |
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1250 | Omega-3-acid ethyl esters 90, Code 03 K85EE - containing alpha tocopherol as antioxidant | BASF AS Oslo NO | 100003052;100032709 | CEP 2008-330 - Rev 05 | 2025/06/23 | Valid | Chemical | 2025/06/23 | Minor revision|CEP granted|23/06/2025; Notification|Accepted - CEP remains valid|25/07/2023; Notification|CEP granted|21/01/2020 |
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1563 | Simvastatin, BHA, Process II | SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN | 100023303;100032437 | CEP 2025-108 - Rev 00 | 2025/06/23 | Valid | 23/06/2030 | Chemical | 2025/06/23 | New application|CEP granted|23/06/2025 |