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
2331 Rabeprazole sodium hydrate METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2020-387 - Rev 01 2024/06/21 Valid 26/08/2027 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|26/08/2022
412 Sodium citrate JUNGBUNZLAUER LADENBURG GMBH Ladenburg DE 100014785;100073136 CEP 2018-273 - Rev 04 2024/06/21 Valid 28/01/2025 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
Notification|Accepted - CEP remains valid|24/08/2023;
Minor revision|CEP granted|01/09/2022;
Minor revision|CEP granted|09/06/2021;
Minor revision|CEP granted|04/06/2020
2923 Esomeprazole sodium METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2020-214 - Rev 01 2024/06/21 Valid 30/05/2027 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|30/05/2022
1028 Metoprolol tartrate MICROSIN S.R.L. Bucharest RO 100020983;100029693 CEP 2010-138 - Rev 01 2024/06/21 Valid Chemical 2024/06/21 Minor revision|CEP granted|21/06/2024
972 Antazoline hydrochloride METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2020-060 - Rev 02 2024/06/21 Valid 12/07/2026 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
Administrative procedure|CEP granted|09/03/2022;
New application|CEP granted|12/07/2021
2296 Pantoprazole sodium sesquihydrate METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2021-168 - Rev 01 2024/06/21 Valid 12/09/2027 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|12/09/2022
111 Zinc sulfate heptahydrate METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2022-422 - Rev 01 2024/06/21 Valid 19/05/2028 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|19/05/2023
2296 Pantoprazole sodium sesquihydrate, PAS Process METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2023-127 - Rev 01 2024/06/21 Valid 16/06/2028 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|16/06/2023
2331 Rabeprazole sodium hydrate, RBL process METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2022-429 - Rev 01 2024/06/21 Valid 05/01/2028 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|05/01/2023
110 Zinc chloride METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2022-426 - Rev 01 2024/06/21 Valid 22/05/2028 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|22/05/2023
1075 Budesonide CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2006-061 - Rev 03 2024/06/21 Valid Chemical 2024/06/21 Minor revision|CEP granted|21/06/2024;
Minor revision|CEP granted|23/09/2022
1751 Fosinopril sodium SIEGFRIED EVIONNAZ SA Evionnaz CH 100011796;100019013 CEP 2021-425 - Rev 00 2024/06/21 Valid 21/06/2029 Chemical 2024/06/21 New application|CEP granted|21/06/2024
2594 Duloxetine hydrochloride, Milled, micronised Moehs Iberica S.L. Rubi ES 100029092;100068825 CEP 2012-319 - Rev 01 2024/06/21 Valid Chemical 2024/06/21 Minor revision|CEP granted|21/06/2024;
Minor revision|Accepted - CEP remains valid|21/12/2021
2856 Pirfenidone APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2018-098 - Rev 03 2024/06/21 Valid Chemical 2024/06/21 Renewal|CEP granted|21/06/2024;
Notification|CEP granted|13/12/2023;
Minor revision|Accepted - CEP remains valid|17/02/2023;
Notification|Rejected|27/01/2023;
Minor revision|CEP granted|09/03/2022
2932 Rivaroxaban COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2020-274 - Rev 01 2024/06/21 Valid 09/12/2026 Chemical 2024/06/21 Minor revision|CEP granted|21/06/2024;
Notification|Accepted - CEP remains valid|10/11/2023;
Notification|Accepted - CEP remains valid|10/02/2022;
New application|CEP granted|09/12/2021
2414 Octreotide SINOPEP-ALLSINO BIOPHARMACEUTICAL CO., LTD. Lianyungang CN 100034355;100054452 CEP 2022-302 - Rev 00 2024/06/21 Valid 21/06/2029 Chemical 2024/06/21 New application|CEP granted|21/06/2024
2771 Ibandronate sodium monohydrate FLEMING LABORATORIES LIMITED Hyderabad IN 100015641;100067279 CEP 2022-338 - Rev 00 2024/06/21 Valid 21/06/2029 Chemical 2024/06/21 New application|CEP granted|21/06/2024
894 Copper sulfate pentahydrate METROCHEM API PRIVATE LIMITED Hyderabad IN 100045158;100074519 CEP 2022-438 - Rev 01 2024/06/21 Valid 22/02/2029 Chemical 2024/06/21 Notification|CEP granted|21/06/2024;
New application|CEP granted|22/02/2024
1181 Buprenorphine hydrochloride, Site A AREVIPHARMA GMBH Radebeul DE 100011616;100022155 CEP 2021-431 - Rev 01 2024/06/21 Valid 21/01/2027 Chemical 2024/06/21 Major revision|CEP granted|21/06/2024;
New application|CEP granted|21/01/2022
3132 Mirabegron Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN 100020812;100083553 CEP 2023-180 - Rev 00 2024/06/21 Valid 21/06/2029 Chemical 2024/06/21 New application|CEP granted|21/06/2024

数据库说明:

当前数据更新日期:2024年06月25日。
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