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
1768 Valaciclovir hydrochloride AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2022-123 - Rev 01 2025/06/03 Valid 24/10/2027 Chemical 2025/06/03 Minor revision|CEP granted|03/06/2025;
New application|CEP granted|24/10/2022
3132 Mirabegron SHANDONG LONCOM PHARMACEUTICAL CO., LTD Dezhou CN 100048642;100080616 CEP 2023-286 - Rev 00 2025/06/03 Valid 03/06/2030 Chemical 2025/06/03 New application|CEP granted|03/06/2025
. Bovine pericardium, Glutaraldehyde-fixed JENSCARE SCIENTIFIC CO., LTD. Ningbo CN 100049513;100085009 CEP 2024-288 - Rev 01 2025/06/03 Valid 17/02/2030 TSE 2025/06/03 Notification|CEP granted|03/06/2025;
New application|CEP granted|17/02/2025
1705 Sertraline hydrochloride, Process-VI SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2025-041 - Rev 00 2025/06/03 Valid 03/06/2030 Chemical 2025/06/03 New application|CEP granted|03/06/2025
2154 Telmisartan, WT6 process IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2024-457 - Rev 01 2025/06/03 Valid 29/01/2030 Chemical 2025/06/03 Minor revision|CEP granted|03/06/2025;
New application|CEP granted|29/01/2025
1076 Bumetanide HAINAN POLY PHARMACEUTICAL COMPANY LIMITED Haikou CN 100024397;100033569 CEP 2024-510 - Rev 00 2025/06/03 Valid 03/06/2030 Chemical 2025/06/03 New application|CEP granted|03/06/2025
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
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

数据库说明:

当前数据更新日期:2026年04月03日。
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