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
572 Timolol maleate CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN 100018245;100028824 CEP 2010-084 - Rev 05 2026/05/20 Valid Chemical 2026/05/20 Minor revision|CEP granted|20/05/2026;
Minor revision|CEP granted|22/12/2025;
Notification|CEP granted|20/10/2023
2223 Glimepiride, Micronised, polymorph form I USV PRIVATE LIMITED Mumbai IN 100006251;100010851 CEP 2006-243 - Rev 06 2026/05/20 Valid Chemical 2026/05/20 Major revision|CEP granted|20/05/2026;
Minor revision|Accepted - CEP remains valid|21/07/2023;
Minor revision|CEP granted|18/05/2022;
Minor revision|CEP granted|23/11/2020
829 Hydralazine hydrochloride SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100099917 CEP 2013-191 - Rev 04 2026/05/20 Valid Chemical 2026/05/20 Major revision|CEP granted|20/05/2026;
Minor revision|CEP granted|26/06/2024;
Monograph revision|CEP granted|02/06/2022;
Minor revision|Accepted - CEP remains valid|21/09/2021;
Notification|Rejected|30/07/2021;
Major revision|CEP granted|02/03/2021
2576 Voriconazole MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN 100051463;100098142 CEP 2011-298 - Rev 05 2026/05/20 Valid Chemical 2026/05/20 Minor revision|CEP granted|20/05/2026;
Notification|CEP granted|19/07/2024;
Notification|CEP granted|31/08/2021;
Minor revision|CEP granted|25/05/2021
2232 Losartan potassium ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2009-133 - Rev 10 2026/05/20 Valid Chemical 2026/05/20 Minor revision|CEP granted|20/05/2026;
Minor revision|Accepted - CEP remains valid|19/06/2025;
Minor revision|CEP granted|28/02/2025;
Minor revision|CEP granted|23/03/2023;
Minor revision|Accepted - CEP remains valid|04/01/2023;
Minor revision|Accepted - CEP remains valid|30/08/2022;
Notification|CEP granted|07/07/2022;
Major revision|CEP granted|03/01/2022;
Minor revision|CEP granted|15/01/2021;
Minor revision|CEP granted|11/06/2020
1448 Metoprolol succinate CTX LIFESCIENCES PRIVATE LIMITED Surat IN 100019102;100027863 CEP 2008-198 - Rev 04 2026/05/20 Valid Chemical 2026/05/20 Minor revision|CEP granted|20/05/2026;
Minor revision|Accepted - CEP remains valid|29/09/2023;
Minor revision|Accepted - CEP remains valid|29/06/2021
1414 Detomidine hydrochloride for veterinary use CHEMISCH-PHARMAZEUTISCHES LABOR ROLF SACHSE GMBH Berlin DE 100013251;100022210 CEP 2019-225 - Rev 01 2026/05/20 Valid Chemical 2026/05/20 Renewal|CEP granted|20/05/2026
2733 Escitalopram oxalate SMS PHARMACEUTICALS LIMITED Hyderabad IN 100011780;100061058 CEP 2025-082 - Rev 00 2026/05/20 Valid 20/05/2031 Chemical 2026/05/20 New application|CEP granted|20/05/2026
2119 Venlafaxine hydrochloride, Process II, Form-II ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2021-093 - Rev 02 2026/05/20 Valid Chemical 2026/05/20 Renewal|CEP granted|20/05/2026;
Notification|CEP granted|12/07/2022;
New application|CEP granted|16/07/2021
3121 Etravirine, Form-I MSN LIFE SCIENCES PRIVATE LIMITED Medak IN 100018316;100027671 CEP 2025-023 - Rev 00 2026/05/20 Valid 20/05/2031 Chemical 2026/05/20 New application|CEP granted|20/05/2026
1073 Biotin ZHEJIANG SHENGDA BIO-PHARM CO., LTD. Tiantai CN 100024864;100041389 CEP 2019-320 - Rev 01 2026/05/20 Valid Chemical 2026/05/20 Renewal|CEP granted|20/05/2026
335 Hydrocortisone CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2018-045 - Rev 03 2026/05/20 Valid Chemical 2026/05/20 Monograph revision|CEP granted|20/05/2026;
Renewal|CEP granted|21/10/2024;
Notification|CEP granted|25/08/2021
2541 Quetiapine Fumarate, QTR Process UNICHEM LABORATORIES LIMITED Mumbai IN 100005397;100093080 CEP 2025-581 - Rev 00 2026/05/20 Valid 20/05/2031 Chemical 2026/05/20 New application|CEP granted|20/05/2026
1472 Sodium hyaluronate, HYALURONASAN HA-SHL 150: Intrinsic viscosity 2.00 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use KEWPIE CORP. Tokyo JP 100039277;100093553 CEP 2025-641 - Rev 00 2026/05/20 Valid 20/05/2031 Chemical and TSE 2026/05/20 New application|CEP granted|20/05/2026
926 Levonorgestrel, Dorog site GEDEON RICHTER PLC. Budapest X HU 100000640;100001653 CEP 2025-615 - Rev 00 2026/05/20 Valid 20/05/2031 Chemical 2026/05/20 New application|CEP granted|20/05/2026
3137 Dapagliflozin propylene glycol monohydrate NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2025-083 - Rev 00 2026/05/20 Valid 20/05/2031 Chemical 2026/05/20 New application|CEP granted|20/05/2026
1009 Domperidone, Micronised HRV GLOBAL LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100051231;100089696 CEP 2024-243 - Rev 00 2026/05/19 Valid 19/05/2031 Chemical 2026/05/19 New application|CEP granted|19/05/2026
817 Cyproheptadine hydrochloride 1.5-hydrate VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2024-367 - Rev 00 2026/05/19 Valid 19/05/2031 Chemical 2026/05/19 New application|CEP granted|19/05/2026
755 Carbidopa MAITHRI DRUGS PRIVATE LIMITED Bonthapally IN 100020971;100029680 CEP 2020-143 - Rev 01 2026/05/19 Valid Chemical 2026/05/19 Renewal|CEP granted|19/05/2026;
New application|CEP granted|11/06/2021
562 Sodium cromoglicate AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2024-052 - Rev 01 2026/05/19 Valid 11/04/2030 Chemical 2026/05/19 Minor revision|CEP granted|19/05/2026;
New application|CEP granted|11/04/2025

数据库说明:

当前数据更新日期:2026年05月22日。
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