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
1140 Potassium clavulanate SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN 100033465;100082197 CEP 2014-320 - Rev 01 2025/06/02 Valid Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
Renewal|CEP granted|05/03/2021
654 Beclometasone dipropionate AVIK PHARMACEUTICAL LIMITED Vapi IN 100023327;100041968 CEP 2014-036 - Rev 02 2025/06/02 Valid Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
Major revision|CEP granted|30/07/2024;
Notification|Accepted - CEP remains valid|17/06/2022;
Renewal|CEP granted|03/11/2020
1705 Sertraline hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2008-265 - Rev 02 2025/06/02 Valid Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
Notification|Accepted - CEP remains valid|28/07/2021;
Minor revision|Accepted - CEP remains valid|05/01/2021;
Notification|CEP granted|27/05/2020
576 Allopurinol IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2008-211 - Rev 05 2025/06/02 Valid Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
Minor revision|Accepted - CEP remains valid|12/03/2024;
Minor revision|CEP granted|27/01/2023;
Minor revision|Accepted - CEP remains valid|21/02/2022;
Minor revision|CEP granted|19/08/2020
729 Naloxone hydrochloride dihydrate NORAMCO, LLC. Wilmington US 100048651;100080628 CEP 2011-055 - Rev 04 2025/06/02 Valid Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
Minor revision|CEP granted|06/09/2023;
Notification|CEP granted|18/03/2022;
Notification|CEP granted|05/03/2020
3139 Brivaracetam ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2024-088 - Rev 00 2025/06/02 Valid 02/06/2030 Chemical 2025/06/02 New application|CEP granted|02/06/2025
2760 Brimonidine tartrate MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2019-335 - Rev 03 2025/06/02 Valid Chemical 2025/06/02 Renewal|CEP granted|02/06/2025;
Notification|CEP granted|18/04/2024;
Major revision|CEP granted|07/02/2022;
Minor revision|Rejected|17/11/2021
1354 Oxybutynin hydrochloride THINQ PHARMA-CRO LIMITED Thane IN 100042194;100069636 CEP 2024-057 - Rev 00 2025/06/02 Valid 02/06/2030 Chemical 2025/06/02 New application|CEP granted|02/06/2025
714 Doxorubicin Hydrochloride DZD (HEZE) PHARMACEUTICAL CO., LTD. Heze City CN 100039412;100062056 CEP 2016-254 - Rev 01 2025/06/02 Valid Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
Renewal|CEP granted|22/11/2022
2849 Hydroxychloroquine sulfate ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2019-011 - Rev 02 2025/06/02 Valid Chemical 2025/10/24 Minor revision|Accepted - CEP remains valid|24/10/2025;
Renewal|CEP granted|02/06/2025;
Minor revision|Accepted - CEP remains valid|20/09/2024;
Notification|CEP granted|08/07/2022;
Minor revision|Accepted - CEP remains valid|15/09/2020
2992 Lacosamide, Process II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-128 - Rev 02 2025/06/02 Valid 04/07/2029 Chemical 2025/06/02 Administrative procedure|CEP granted|02/06/2025;
Minor revision|CEP granted|26/05/2025;
New application|CEP granted|04/07/2024
3095 Dabigatran etexilate mesilate, Form-I ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2024-262 - Rev 00 2025/06/02 Valid 02/06/2030 Chemical 2025/06/02 New application|CEP granted|02/06/2025
2762 Capecitabine, Process-III INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2025-176 - Rev 00 2025/06/02 Valid 02/06/2030 Chemical 2025/06/02 New application|CEP granted|02/06/2025
2585 Rizatriptan benzoate, 1295 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2025-054 - Rev 00 2025/06/02 Valid 02/06/2030 Chemical 2025/06/02 New application|CEP granted|02/06/2025
778 Oxazepam R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN 100016723;100053383 CEP 2024-383 - Rev 00 2025/06/02 Valid 02/06/2030 Chemical 2025/06/02 New application|CEP granted|02/06/2025
2173 Gabapentin, Process V ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2024-148 - Rev 01 2025/06/02 Valid 19/07/2029 Chemical 2025/06/02 Minor revision|CEP granted|02/06/2025;
New application|CEP granted|19/07/2024
1558 Propofol SI GROUP, INC. The Woodlands US 100025308;100077018 CEP 2002-229 - Rev 05 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Minor revision|CEP granted|26/10/2023;
Notification|CEP granted|22/08/2022
2541 Quetiapine Fumarate MEGA FINE PHARMA PRIVATE LIMITED Mumbai IN 100011550;100021133 CEP 2014-198 - Rev 02 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Minor revision|CEP granted|21/11/2023
1632 Celiprolol hydrochloride MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 2007-220 - Rev 05 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Minor revision|CEP granted|08/03/2024;
Minor revision|Accepted - CEP remains valid|24/10/2022;
Monograph revision|CEP granted|24/03/2021
2421 Ziprasidone hydrochloride monohydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2012-131 - Rev 02 2025/05/30 Valid Chemical 2025/05/30 Minor revision|CEP granted|30/05/2025;
Notification|CEP granted|11/01/2024;
Minor revision|Accepted - CEP remains valid|17/11/2021;
Minor revision|Accepted - CEP remains valid|29/04/2021

数据库说明:

当前数据更新日期:2026年02月11日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM