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
14 Calcium carbonate SUDEEP PHARMA LIMITED Vadodara IN 100033274;100051937 CEP 2013-299 - Rev 03 2025/03/11 Valid Chemical 2025/03/11 Notification|CEP granted|11/03/2025;
Minor revision|CEP granted|31/08/2022
1653 Potassium clavulanate, diluted, With microcrystalline cellulose in the ratio 1:1 SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN 100025540;100034769 CEP 2011-375 - Rev 03 2025/03/11 Valid Chemical 2025/03/11 Notification|CEP granted|11/03/2025;
Minor revision|Accepted - CEP remains valid|29/02/2024;
Minor revision|Accepted - CEP remains valid|04/10/2022;
Minor revision|CEP granted|08/04/2021;
Minor revision|Accepted - CEP remains valid|20/02/2020
2244 Tacrolimus monohydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2018-233 - Rev 06 2025/03/11 Valid Chemical 2025/03/11 Administrative procedure|CEP granted|11/03/2025;
Notification|CEP granted|04/03/2025;
Renewal|CEP granted|05/08/2024;
Minor revision|Accepted - CEP remains valid|17/11/2023;
Minor revision|CEP granted|25/11/2022;
Major revision|CEP granted|06/04/2022;
Minor revision|Rejected|04/11/2021;
Minor revision|CEP granted|01/09/2020
14 Calcium carbonate, Granular SUDEEP PHARMA LIMITED Vadodara IN 100033274;100051937 CEP 2020-379 - Rev 02 2025/03/11 Valid 21/04/2026 Chemical 2025/03/11 Notification|CEP granted|11/03/2025;
Minor revision|CEP granted|02/09/2022;
New application|CEP granted|21/04/2021
475 Chlorpromazine hydrochloride MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN 100013041;100021615 CEP 2021-018 - Rev 03 2025/03/11 Valid 01/08/2027 Chemical 2025/03/11 Minor revision|CEP granted|11/03/2025;
Notification|CEP granted|15/02/2023;
Administrative procedure|CEP granted|30/08/2022;
New application|CEP granted|01/08/2022
3036 Teriflunomide ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2023-135 - Rev 01 2025/03/11 Valid 25/07/2029 Chemical 2025/03/11 Minor revision|CEP granted|11/03/2025;
New application|CEP granted|26/07/2024
2335 Ropivacaine hydrochloride monohydrate EDMOND PHARMA S.R.L. Paderno Dugnano IT 100000246;100002746 CEP 2007-342 - Rev 04 2025/03/11 Valid Chemical 2025/03/11 Notification|CEP granted|11/03/2025;
Minor revision|Accepted - CEP remains valid|31/07/2023;
Notification|Rejected|15/05/2023;
Minor revision|CEP granted|15/07/2021
1673 Isoflurane SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN 100025540;100034769 CEP 2010-078 - Rev 01 2025/03/11 Valid Chemical 2025/03/24 Minor revision|Accepted - CEP remains valid|24/03/2025;
Notification|CEP granted|11/03/2025;
Minor revision|Accepted - CEP remains valid|04/09/2020
1275 Ursodeoxycholic acid ARCH PHARMALABS LIMITED Mumbai IN 100011823;100095249 CEP 2019-029 - Rev 06 2025/03/11 Valid Chemical and TSE 2025/10/15 Renewal|Accepted - CEP remains valid|15/10/2025;
Notification|CEP granted|11/03/2025;
Minor revision|CEP granted|17/06/2024;
Minor revision|CEP granted|07/02/2024;
Notification|CEP granted|04/12/2023;
Minor revision|CEP granted|23/08/2023;
Minor revision|CEP granted|19/12/2022
1373 Testosterone SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN 100048889;100089578 CEP 2023-267 - Rev 00 2025/03/11 Valid 11/03/2030 Chemical 2025/03/11 New application|CEP granted|11/03/2025
673 Medroxyprogesterone acetate, Crystalline TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-153 - Rev 05 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Notification|CEP granted|23/11/2021;
Minor revision|CEP granted|11/03/2021;
Notification|CEP granted|07/08/2020
611 Fluorouracil TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2005-113 - Rev 06 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Minor revision|Accepted - CEP remains valid|04/03/2024;
Minor revision|Abandoned|13/09/2023;
Notification|CEP granted|22/11/2021;
Minor revision|CEP granted|13/04/2021
673 Medroxyprogesterone acetate, Micronised (M1, M2, M3) TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-276 - Rev 06 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Notification|CEP granted|23/11/2021;
Minor revision|CEP granted|13/04/2021
599 Cisplatin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-411 - Rev 04 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Monograph revision|CEP granted|18/10/2022
2017 Oxaliplatin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2005-259 - Rev 04 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Notification|CEP granted|22/11/2021;
Minor revision|CEP granted|29/01/2021
1225 Hydroxyethyl salicylate UBE CORP. Ube JP 100012830;100068667 CEP 2014-078 - Rev 02 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Notification|Accepted - CEP remains valid|29/01/2024;
Monograph revision|CEP granted|04/04/2023;
Renewal|CEP granted|15/03/2022
2019 Perindopril tert-butylamine HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2010-118 - Rev 05 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Minor revision|Accepted - CEP remains valid|05/04/2024;
Minor revision|Accepted - CEP remains valid|27/03/2023;
Minor revision|CEP granted|27/07/2021;
Minor revision|Accepted - CEP remains valid|09/11/2020;
Monograph revision|Accepted - CEP remains valid|10/06/2020
1449 Mometasone furoate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-198 - Rev 04 2025/03/10 Valid Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Minor revision|CEP granted|06/04/2023;
Notification|CEP granted|17/02/2022
1764 Rocuronium bromide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-023 - Rev 06 2025/03/10 Valid Chemical 2025/10/17 Minor revision|Accepted - CEP remains valid|17/10/2025;
Notification|CEP granted|10/03/2025;
Minor revision|CEP granted|21/08/2024;
Minor revision|CEP granted|25/07/2022;
Notification|CEP granted|22/11/2021
429 Progesterone, Micronised LA CHANDRA PHARMALAB PRIVATE LIMITED Ahmedabad IN 100048266;100079876 CEP 2023-385 - Rev 00 2025/03/10 Valid 10/03/2030 Chemical 2025/03/10 New application|CEP granted|10/03/2025

数据库说明:

当前数据更新日期:2025年12月09日。
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