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
3095 Dabigatran etexilate mesilate, Form-I BIOCON LIMITED Pashamylaram IN 100011487;100021549 CEP 2024-046 - Rev 00 2025/10/09 Valid 09/10/2030 Chemical 2025/10/09 New application|CEP granted|09/10/2025
653 Baclofen VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100040217;100065484 CEP 2024-145 - Rev 00 2025/10/09 Valid 09/10/2030 Chemical 2025/10/09 New application|CEP granted|09/10/2025
771 Leucine SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN 100025187;100034386 CEP 2010-189 - Rev 01 2025/10/08 Valid Chemical 2025/10/08 Notification|CEP granted|08/10/2025;
Minor revision|Accepted - CEP remains valid|18/11/2024;
Minor revision|Accepted - CEP remains valid|18/06/2024;
Minor revision|Accepted - CEP remains valid|22/11/2022
369 Azathioprine, Process 2 AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2014-030 - Rev 02 2025/10/08 Valid Chemical 2025/10/08 Minor revision|CEP granted|08/10/2025;
Minor revision|Accepted - CEP remains valid|29/01/2024;
Notification|CEP granted|20/10/2022;
Minor revision|Accepted - CEP remains valid|10/06/2022
785 Proline SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN 100025187;100034386 CEP 2010-263 - Rev 02 2025/10/08 Valid Chemical 2025/10/08 Notification|CEP granted|08/10/2025;
Notification|CEP granted|11/06/2024;
Minor revision|Accepted - CEP remains valid|11/08/2023;
Notification|Accepted - CEP remains valid|09/02/2022;
Minor revision|Accepted - CEP remains valid|18/11/2021
653 Baclofen MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2006-229 - Rev 03 2025/10/08 Valid Chemical 2025/10/08 Notification|CEP granted|08/10/2025;
Notification|CEP granted|26/07/2024
2992 Lacosamide LEE PHARMA LIMITED Hyderabad IN 100014849;100042625 CEP 2019-223 - Rev 01 2025/10/08 Valid 21/10/2026 Chemical 2025/10/08 Minor revision|CEP granted|08/10/2025
926 Levonorgestrel, Micronised, Process II QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN 100016470;100025257 CEP 2022-225 - Rev 02 2025/10/08 Valid 20/12/2027 Chemical 2025/10/08 Administrative procedure|CEP granted|08/10/2025;
Notification|CEP granted|23/09/2025;
New application|CEP granted|20/12/2022
711 Cyclophosphamide monohydrate SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2020-083 - Rev 03 2025/10/08 Valid 27/08/2026 Chemical 2025/10/08 Minor revision|CEP granted|08/10/2025;
Monograph revision|CEP granted|09/01/2023;
Notification|CEP granted|21/07/2022;
New application|CEP granted|27/08/2021
20 Dextromethorphan hydrobromide monohydrate WANBURY LIMITED Vashi, Navi Mumbai IN 100021364;100030068 CEP 2022-268 - Rev 01 2025/10/08 Valid 03/09/2029 Chemical 2025/10/08 Monograph revision|CEP granted|08/10/2025;
New application|CEP granted|03/09/2024
2191 Atorvastatin calcium MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-184 - Rev 05 2025/10/07 Valid Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Minor revision|CEP granted|27/09/2024;
Notification|CEP granted|29/07/2024;
Monograph revision|CEP granted|10/08/2022
913 Hydroxocobalamin acetate EUROAPI FRANCE Paris FR 100039327;100097848 CEP 2001-179 - Rev 10 2025/10/07 Valid Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Notification|Accepted - CEP remains valid|01/04/2025;
Notification|CEP granted|01/08/2024;
Notification|CEP granted|09/02/2024;
Minor revision|CEP granted|28/07/2022;
Minor revision|Accepted - CEP remains valid|04/03/2020
2423 Valsartan MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2009-396 - Rev 08 2025/10/07 Valid Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Notification|CEP granted|26/07/2024;
Minor revision|CEP granted|23/02/2022
1564 Sodium alendronate trihydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2009-290 - Rev 03 2025/10/07 Valid Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Notification|CEP granted|26/07/2024
914 Hydroxocobalamin chloride EUROAPI FRANCE Paris FR 100039327;100097848 CEP 2001-437 - Rev 09 2025/10/07 Valid Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Notification|Accepted - CEP remains valid|12/05/2025;
Minor revision|CEP granted|05/07/2024;
Notification|CEP granted|09/02/2024;
Minor revision|CEP granted|22/08/2022;
Notification|CEP granted|30/11/2021
2423 Valsartan, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2024-007 - Rev 02 2025/10/07 Valid 12/06/2029 Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Notification|CEP granted|26/07/2024;
New application|CEP granted|12/06/2024
1705 Sertraline hydrochloride, Process-II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2023-151 - Rev 04 2025/10/07 Valid 12/07/2028 Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Minor revision|CEP granted|08/07/2025;
Administrative procedure|CEP granted|01/08/2024;
Notification|CEP granted|25/07/2024;
New application|CEP granted|12/07/2023
2270 Sildenafil citrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-317 - Rev 03 2025/10/07 Valid Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Minor revision|CEP granted|05/03/2025;
Notification|CEP granted|25/07/2024
2857 Trazodone hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2023-159 - Rev 01 2025/10/07 Valid 08/08/2029 Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Minor revision|Accepted - CEP remains valid|17/04/2025;
New application|CEP granted|08/08/2024
2423 Valsartan, Process III MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2024-113 - Rev 02 2025/10/07 Valid 14/06/2029 Chemical 2025/10/07 Notification|CEP granted|07/10/2025;
Notification|CEP granted|25/07/2024;
New application|CEP granted|14/06/2024

数据库说明:

当前数据更新日期:2025年12月14日。
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