欧洲药典适用性证书数据库
(Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM)
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
1199 Dipyridamole MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-244 - Rev 05 2025/09/30 Valid Chemical 2025/09/30 Notification|CEP granted|30/09/2025;
Notification|CEP granted|30/07/2024;
Major revision|CEP granted|31/03/2022
408 Methadone hydrochloride PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVATE LIMITED Mumbai IN 100014944;100038683 CEP 2003-062 - Rev 02 2025/09/30 Valid Chemical 2025/09/30 Minor revision|CEP granted|30/09/2025;
Notification|CEP granted|03/10/2023
1059 Zidovudine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2007-318 - Rev 07 2025/09/30 Valid Chemical 2025/09/30 Notification|CEP granted|30/09/2025;
Notification|CEP granted|18/07/2024;
Minor revision|CEP granted|03/05/2023;
Monograph revision|Accepted - CEP remains valid|07/01/2022;
Minor revision|CEP granted|27/05/2020
1049 Threonine SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN 100025187;100034386 CEP 2010-044 - Rev 01 2025/09/30 Valid Chemical 2025/09/30 Notification|CEP granted|30/09/2025;
Notification|Accepted - CEP remains valid|07/05/2024;
Minor revision|Accepted - CEP remains valid|08/08/2023;
Minor revision|Accepted - CEP remains valid|20/03/2023
1705 Sertraline hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2008-304 - Rev 05 2025/09/30 Valid Chemical 2025/09/30 Notification|CEP granted|30/09/2025;
Notification|CEP granted|18/07/2024;
Minor revision|CEP granted|24/04/2023;
Major revision|Rejected|23/03/2023
2136 Ritonavir, Form-II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-221 - Rev 03 2025/09/30 Valid Chemical 2025/09/30 Notification|CEP granted|30/09/2025;
Notification|CEP granted|25/07/2024;
Minor revision|Accepted - CEP remains valid|20/09/2023;
Minor revision|CEP granted|06/09/2021
2372 Esomeprazole magnesium trihydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2015-023 - Rev 02 2025/09/30 Valid Chemical 2025/09/30 Notification|CEP granted|30/09/2025;
Notification|CEP granted|29/07/2024;
Renewal|CEP granted|26/11/2021;
Minor revision|CEP granted|09/12/2020
330 Gelatin, Limed bone gelatin NITTA GELATIN INDIA LIMITED Ernakulam IN 100032296;100097649 CEP 2020-193 - Rev 01 2025/09/30 Valid TSE 2025/09/30 Renewal|CEP granted|30/09/2025;
New application|CEP granted|05/01/2021
1665 Betahistine dihydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2022-505 - Rev 02 2025/09/30 Valid 25/08/2028 Chemical 2025/09/30 Notification|CEP granted|30/09/2025;
Notification|CEP granted|18/07/2024;
New application|CEP granted|25/08/2023
2815 Entecavir monohydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2017-043 - Rev 02 2025/09/30 Valid Chemical 2025/09/30 Minor revision|CEP granted|30/09/2025;
Notification|CEP granted|06/12/2023;
Renewal|CEP granted|03/01/2023
2541 Quetiapine Fumarate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2014-224 - Rev 04 2025/09/29 Valid Chemical 2025/09/29 Notification|CEP granted|29/09/2025;
Notification|CEP granted|25/07/2024;
Minor revision|Accepted - CEP remains valid|30/04/2024;
Minor revision|CEP granted|02/12/2022;
Notification|CEP granted|31/08/2021;
Renewal|CEP granted|16/03/2021
2124 Loratadine, Form I ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2007-254 - Rev 04 2025/09/29 Valid Chemical 2025/09/29 Minor revision|CEP granted|29/09/2025;
Notification|CEP granted|07/07/2022;
Minor revision|CEP granted|22/04/2020
2422 Oseltamivir phosphate SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2015-348 - Rev 03 2025/09/29 Valid Chemical 2025/09/29 Minor revision|CEP granted|29/09/2025;
Renewal|CEP granted|28/03/2024;
Major revision|CEP granted|03/12/2021
1794 Paclitaxel, Semi-synthetic process FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN 100011513;100018607 CEP 2008-181 - Rev 12 2025/09/29 Valid Chemical 2025/09/29 Minor revision|CEP granted|29/09/2025;
Major revision|CEP granted|21/03/2025;
Major revision|Accepted - CEP remains valid|31/10/2023;
Major revision|CEP granted|17/10/2022;
Notification|Accepted - CEP remains valid|17/06/2022;
Administrative procedure|CEP granted|09/05/2022;
Major revision|CEP granted|29/04/2022;
Minor revision|Accepted - CEP remains valid|27/11/2020;
Administrative procedure|CEP granted|29/04/2020;
Minor revision|CEP granted|31/03/2020
2591 Celecoxib MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-183 - Rev 06 2025/09/29 Valid Chemical 2025/09/29 Notification|CEP granted|29/09/2025;
Minor revision|CEP granted|27/03/2025;
Notification|CEP granted|18/07/2024;
Minor revision|CEP granted|15/02/2023;
Minor revision|CEP granted|26/09/2022
2606 Tadalafil, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-201 - Rev 04 2025/09/29 Valid Chemical 2025/09/29 Notification|CEP granted|29/09/2025;
Renewal|CEP granted|02/01/2025;
Notification|CEP granted|18/07/2024;
Minor revision|CEP granted|27/02/2023
2733 Escitalopram oxalate, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-130 - Rev 04 2025/09/29 Valid Chemical 2025/09/29 Notification|CEP granted|29/09/2025;
Renewal|CEP granted|21/03/2025;
Notification|CEP granted|29/07/2024;
Minor revision|CEP granted|13/07/2023
2778 Sitagliptin phosphate monohydrate, Crystalline, micronised and non-micronised MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN 100014794;100023345 CEP 2016-262 - Rev 02 2025/09/29 Valid Chemical 2025/09/29 Major revision|CEP granted|29/09/2025;
Renewal|CEP granted|12/01/2024;
Minor revision|Accepted - CEP remains valid|01/03/2022;
Notification|Accepted - CEP remains valid|15/12/2020
2203 Citalopram hydrochloride, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-233 - Rev 03 2025/09/29 Valid Chemical 2025/09/29 Notification|CEP granted|29/09/2025;
Renewal|CEP granted|07/05/2025;
Notification|CEP granted|29/07/2024
2338 Mirtazapine, Process-II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-127 - Rev 04 2025/09/29 Valid Chemical 2025/09/29 Notification|CEP granted|29/09/2025;
Renewal|CEP granted|06/02/2025;
Notification|CEP granted|18/07/2024;
Minor revision|CEP granted|28/10/2022

数据库说明:

当前数据更新日期:2025年12月20日。
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