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
1649 Azithromycin, Dihydrate ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shangyu CN R1-CEP 2013-153 - Rev 03 2023/08/10 Valid Chemical 2024/06/05 Notification|Accepted - CEP remains valid|05/06/2024;
Major revision|CEP granted|10/08/2023;
Minor revision|CEP granted|24/05/2022;
Minor revision|CEP granted|04/11/2021
2114 Lysine acetate, NC Ajinomoto Co., Inc. Tokyo JP R1-CEP 2014-063 - Rev 02 2023/08/10 Valid Chemical 2023/08/10 Monograph revision|CEP granted|10/08/2023;
Notification|CEP granted|27/09/2021;
Renewal|CEP granted|14/10/2020
2593 Docetaxel MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R1-CEP 2015-336 - Rev 01 2023/08/10 Valid Chemical 2023/08/10 Notification|CEP granted|10/08/2023;
Renewal|CEP granted|12/01/2022;
Minor revision|CEP granted|25/11/2020
96 Mercaptopurine monohydrate AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN R0-CEP 2021-275 - Rev 00 2023/08/09 Valid 09/08/2028 Chemical 2023/08/09 New application|CEP granted|09/08/2023
11 Benzocaine APEX HEALTHCARE LIMITED Ankleshwar IN R0-CEP 2022-102 - Rev 00 2023/08/09 Valid 09/08/2028 Chemical 2023/08/09 New application|CEP granted|09/08/2023
2604 Ropinirole hydrochloride ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN R0-CEP 2022-227 - Rev 00 2023/08/09 Valid 09/08/2028 Chemical 2023/08/09 New application|CEP granted|09/08/2023
1654 Lymecycline, Type 2 OLON S.P.A. Rodano IT R0-CEP 2023-172 - Rev 00 2023/08/09 Valid 09/08/2028 Chemical 2023/08/09 New application|CEP granted|09/08/2023
1013 Felodipine ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN R1-CEP 2013-307 - Rev 02 2023/08/09 Valid Chemical 2023/08/09 Minor revision|CEP granted|09/08/2023;
Monograph revision|CEP granted|22/03/2023
2888 Rupatadine fumarate URQUIMA S.A. Palau-solità i Plegamans ES R1-CEP 2017-202 - Rev 00 2023/08/09 Valid Chemical 2023/08/09 Renewal|CEP granted|09/08/2023;
Minor revision|CEP granted|14/12/2022;
Notification|Rejected|07/10/2022
3087 Ticagrelor Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN R0-CEP 2021-303 - Rev 00 2023/08/08 Valid 08/08/2028 Chemical 2023/08/08 New application|CEP granted|08/08/2023
2154 Telmisartan HETERO LABS LIMITED Hyderabad IN R0-CEP 2022-041 - Rev 00 2023/08/08 Valid 08/08/2028 Chemical 2023/08/08 New application|CEP granted|08/08/2023
285 Noradrenaline tartrate HARMAN FINOCHEM LIMITED Mumbai IN R0-CEP 2022-253 - Rev 00 2023/08/08 Valid 08/08/2028 Chemical 2024/06/14 Minor revision|Accepted - CEP remains valid|14/06/2024;
New application|CEP granted|08/08/2023
2054 Clofazimine ARENE LIFE SCIENCES PRIVATE LIMITED Sangareddy IN R0-CEP 2023-008 - Rev 00 2023/08/08 Valid 08/08/2028 Chemical 2023/08/08 New application|CEP granted|08/08/2023
729 Naloxone hydrochloride dihydrate, Code 1492 SPECGX LLC Webster Groves US R1-CEP 2009-294 - Rev 01 2023/08/08 Valid Chemical 2023/08/08 Minor revision|CEP granted|08/08/2023;
Notification|Accepted - CEP remains valid|06/08/2021
. Bovine pericardium BRAILE BIOMEDICA INDUSTRIA, COMERCIO E REPRESENTACOES LTDA. São José do Rio Preto BR R1-CEP 2018-114 - Rev 00 2023/08/08 Valid TSE 2023/08/08 Renewal|CEP granted|08/08/2023
2733 Escitalopram oxalate, Process-III NEULAND LABORATORIES LIMITED Hyderabad IN R0-CEP 2021-161 - Rev 01 2023/08/07 Valid 27/07/2026 Chemical 2024/03/06 Minor revision|Accepted - CEP remains valid|06/03/2024;
Minor revision|CEP granted|07/08/2023;
Minor revision|Accepted - CEP remains valid|02/02/2022;
New application|CEP granted|27/07/2021
2244 Tacrolimus monohydrate LEK PHARMACEUTICALS D.D. Ljubljana SI R0-CEP 2021-204 - Rev 01 2023/08/07 Valid 02/12/2027 Chemical 2023/08/07 Notification|CEP granted|07/08/2023;
New application|CEP granted|02/12/2022
1187 Carmustine NERPHARMA S.R.L. Nerviano IT R0-CEP 2021-212 - Rev 00 2023/08/07 Valid 07/08/2028 Chemical 2023/08/07 New application|CEP granted|07/08/2023
2932 Rivaroxaban MEGAFINE PHARMA (P) LIMITED Mumbai IN R0-CEP 2021-277 - Rev 01 2023/08/07 Valid 13/05/2027 Chemical 2023/08/07 Minor revision|CEP granted|07/08/2023;
New application|CEP granted|16/05/2022
1558 Propofol GUANGDONG JIABO PHARMACEUTICAL CO., LTD. Qingyuan CN R0-CEP 2022-494 - Rev 00 2023/08/07 Valid 07/08/2028 Chemical 2024/05/17 Notification|Accepted - CEP remains valid|17/05/2024;
New application|CEP granted|07/08/2023

数据库说明:

当前数据更新日期:2024年08月17日。
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