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
2114 Lysine acetate EVONIK REXIM S.A.S. Ham FR 100012329;100020964 CEP 2010-155 - Rev 04 2025/04/02 Valid Chemical 2025/04/02 Notification|CEP granted|02/04/2025;
Monograph revision|CEP granted|24/01/2024;
Notification|CEP granted|14/03/2022
1611 Diosmin, Non-micronised, micronised CHENGDU RUNDE PHARMACEUTICAL CO. LTD. Chengdu CN 100024824;100095430 CEP 2012-180 - Rev 03 2025/04/02 Valid Chemical 2025/04/02 Notification|CEP granted|02/04/2025;
Minor revision|Accepted - CEP remains valid|20/02/2025;
Minor revision|Accepted - CEP remains valid|11/07/2023;
Minor revision|Accepted - CEP remains valid|01/02/2022;
Minor revision|CEP granted|07/06/2021;
Minor revision|CEP granted|12/06/2020
1357 Pheniramine maleate SUPRIYA LIFESCIENCE LIMITED Mumbai IN 100015796;100024574 CEP 2015-030 - Rev 01 2025/04/02 Valid Chemical 2025/04/02 Major revision|CEP granted|02/04/2025;
Minor revision|Rejected|05/09/2024;
Renewal|CEP granted|18/03/2022
1173 Benserazide hydrochloride COHANCE LIFESCIENCES LIMITED Hyderabad IN 100011755;100021186 CEP 2023-115 - Rev 00 2025/04/02 Valid 02/04/2030 Chemical 2025/04/02 New application|CEP granted|02/04/2025
633 Pilocarpine hydrochloride ZHEJIANG AUSUN PHARMACEUTICAL CO., LTD. Taizhou CN 100014719;100023221 CEP 2023-367 - Rev 00 2025/04/02 Valid 02/04/2030 Chemical 2025/04/02 New application|CEP granted|02/04/2025
2779 Solifenacin succinate SMS PHARMACEUTICALS LIMITED Hyderabad IN 100011780;100061058 CEP 2023-388 - Rev 00 2025/04/01 Valid 01/04/2030 Chemical 2025/04/01 New application|CEP granted|01/04/2025
576 Allopurinol TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-007 - Rev 08 2025/04/01 Valid Chemical 2025/04/01 Minor revision|CEP granted|01/04/2025;
Major revision|CEP granted|21/07/2023;
Minor revision|CEP granted|30/03/2022;
Minor revision|Accepted - CEP remains valid|18/11/2020
2888 Rupatadine fumarate VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2018-180 - Rev 03 2025/04/01 Valid Chemical 2025/04/01 Renewal|CEP granted|01/04/2025;
Notification|CEP granted|02/02/2023;
Minor revision|CEP granted|12/09/2022
2373 Meloxicam, Process-II ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2025-010 - Rev 00 2025/04/01 Valid 01/04/2030 Chemical 2025/04/01 New application|CEP granted|01/04/2025
1705 Sertraline hydrochloride, Polymorphic Form-I, Process-2, Viyash Life Sciences Private Limited Unit-II, SLH VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100040217;100065484 CEP 2024-498 - Rev 00 2025/04/01 Valid 01/04/2030 Chemical 2025/04/01 New application|CEP granted|01/04/2025
253 Ascorbic acid Ningxia Qiyuan Pharmaceutical Co., Ltd. Yinchuan CN 100019114;100027878 CEP 2018-181 - Rev 02 2025/03/28 Valid Chemical 2025/03/28 Renewal|CEP granted|28/03/2025;
Notification|Accepted - CEP remains valid|06/01/2025;
Monograph revision|Accepted - CEP remains valid|13/07/2023;
Minor revision|CEP granted|22/06/2022
803 Amiodarone hydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2003-072 - Rev 06 2025/03/28 Valid Chemical 2025/03/28 Monograph revision|CEP granted|28/03/2025;
Notification|CEP granted|15/06/2021;
Minor revision|Accepted - CEP remains valid|13/02/2020
786 Riboflavin sodium phosphate hydrate HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2010-254 - Rev 03 2025/03/28 Valid Chemical 2025/09/22 Minor revision|Accepted - CEP remains valid|22/09/2025;
Administrative procedure|CEP granted|28/03/2025;
Monograph revision|CEP granted|24/03/2025;
Notification|CEP granted|04/09/2020
576 Allopurinol INDOCO REMEDIES LIMITED Mumbai IN 100020134;100061295 CEP 2008-017 - Rev 05 2025/03/28 Valid Chemical 2025/03/28 Minor revision|CEP granted|28/03/2025;
Notification|CEP granted|20/11/2023;
Minor revision|Accepted - CEP remains valid|09/09/2021
1280 Zolpidem tartrate Farmak A.S. Olomouc CZ 100012043;100022687 CEP 2000-319 - Rev 06 2025/03/28 Valid Chemical 2025/03/28 Minor revision|CEP granted|28/03/2025;
Minor revision|CEP granted|02/02/2024;
Notification|Accepted - CEP remains valid|12/04/2022;
Notification|Accepted - CEP remains valid|29/10/2021;
Minor revision|Accepted - CEP remains valid|04/11/2020;
Monograph revision|Accepted - CEP remains valid|19/05/2020
2640 Atomoxetine hydrochloride, Form-A, Process II HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2020-091 - Rev 02 2025/03/28 Valid Chemical 2025/03/28 Renewal|CEP granted|28/03/2025;
Major revision|CEP granted|19/03/2021;
New application|CEP granted|02/06/2020
2414 Octreotide AURO PEPTIDES LIMITED Kandi Mandal IN 100049810;100086899 CEP 2023-017 - Rev 00 2025/03/28 Valid 28/03/2030 Chemical 2025/03/28 New application|CEP granted|28/03/2025
1696 Flunixin meglumine for veterinary use, Process-II SEQUENT SCIENTIFIC LIMITED Mumbai IN 100017805;100032372 CEP 2022-371 - Rev 04 2025/03/28 Valid 05/01/2028 Chemical 2025/03/28 Minor revision|CEP granted|28/03/2025;
Minor revision|CEP granted|04/04/2024;
Minor revision|CEP granted|25/05/2023;
Notification|CEP granted|30/03/2023;
New application|CEP granted|05/01/2023
576 Allopurinol ASSURGEN PHARMA PRIVATE LIMITED Lalamkoduru Village IN 100048048;100079469 CEP 2022-390 - Rev 00 2025/03/28 Valid 28/03/2030 Chemical 2025/03/28 New application|CEP granted|28/03/2025
2017 Oxaliplatin, Process-II SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2024-552 - Rev 00 2025/03/28 Valid 28/03/2030 Chemical 2025/03/28 New application|CEP granted|28/03/2025

数据库说明:

当前数据更新日期:2026年02月10日。
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