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
1338 Lavender oil SCHWABE EXTRACTA GMBH & CO. KG Karlsruhe DE 100021578;100030272 CEP 2015-363 - Rev 02 2025/06/25 Valid Herbal 2025/06/25 Minor revision|CEP granted|25/06/2025;
Minor revision|CEP granted|05/06/2023;
Notification|Accepted - CEP remains valid|17/02/2023;
Renewal|CEP granted|13/09/2022;
Major revision|CEP granted|24/11/2021
1765 Salmeterol xinafoate, Micronised MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN 100014822;100073679 CEP 2020-070 - Rev 02 2025/06/25 Valid Chemical 2025/06/25 Renewal|CEP granted|25/06/2025;
Minor revision|CEP granted|30/08/2021;
New application|CEP granted|14/08/2020
2219 Lansoprazole, Unit IV NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2020-185 - Rev 01 2025/06/25 Valid Chemical 2025/06/25 Renewal|CEP granted|25/06/2025;
New application|CEP granted|26/08/2020
2609 Triclabendazole for veterinary use ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN 100033528;100052489 CEP 2015-109 - Rev 03 2025/06/25 Valid Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
Major revision|CEP granted|03/07/2023;
Minor revision|CEP granted|08/07/2022;
Renewal|CEP granted|18/03/2022
2931 Sorafenib tosilate SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2022-056 - Rev 01 2025/06/25 Valid 10/06/2029 Chemical 2025/06/25 Monograph revision|CEP granted|25/06/2025;
New application|CEP granted|10/06/2024
576 Allopurinol HENAN DONGTAI PHARM CO., LTD. Anyang CN 100023192;100052097 CEP 2023-232 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
1706 Thiamazole MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN 100020971;100029680 CEP 2022-029 - Rev 02 2025/06/25 Valid 28/09/2028 Chemical 2025/06/25 Monograph revision|CEP granted|25/06/2025;
Minor revision|CEP granted|14/05/2024;
New application|CEP granted|28/09/2023
635 Primaquine diphosphate, PQ3 Process IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2022-258 - Rev 01 2025/06/25 Valid 23/06/2028 Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
New application|CEP granted|23/06/2023
1393 Benzbromarone ZHEJIANG CHEMSYN PHARM. CO., LTD. Quzhou CN 100025798;100035044 CEP 2023-109 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
1790 Naltrexone hydrochloride, Process 2 SANECA PHARMACEUTICALS A.S. Hlohovec SK 100002257;100000752 CEP 2025-194 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
2192 Atovaquone, Form A, Process-II HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2025-001 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
2735 Gadobutrol monohydrate MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN 100018316;100070723 CEP 2023-260 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
1724 Formoterol fumarate dihydrate VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2006-227 - Rev 03 2025/06/24 Valid Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Notification|Accepted - CEP remains valid|22/09/2023;
Notification|CEP granted|28/07/2022;
Monograph revision|Accepted - CEP remains valid|06/05/2022
616 Haloperidol MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2020-026 - Rev 03 2025/06/24 Valid 05/01/2027 Chemical 2025/06/24 Administrative procedure|CEP granted|24/06/2025;
Notification|CEP granted|06/06/2025;
Major revision|CEP granted|22/02/2024;
New application|CEP granted|05/01/2022
2002 Proguanil hydrochloride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2011-182 - Rev 01 2025/06/24 Valid Chemical 2025/06/24 Minor revision|CEP granted|24/06/2025;
Notification|Accepted - CEP remains valid|08/01/2024;
Minor revision|Accepted - CEP remains valid|19/04/2022;
Notification|Accepted - CEP remains valid|15/01/2021
1765 Salmeterol xinafoate, Non-micronised and micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2006-226 - Rev 04 2025/06/24 Valid Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Minor revision|CEP granted|05/03/2024;
Notification|CEP granted|28/07/2022
1794 Paclitaxel, Produced by semi-synthetic process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-236 - Rev 06 2025/06/24 Valid Chemical 2025/06/24 Minor revision|CEP granted|24/06/2025;
Major revision|CEP granted|25/11/2024;
Minor revision|CEP granted|27/02/2024;
Minor revision|CEP granted|19/11/2021
616 Haloperidol VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2020-149 - Rev 01 2025/06/24 Valid 04/04/2028 Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Minor revision|Accepted - CEP remains valid|20/08/2024;
Minor revision|Accepted - CEP remains valid|09/01/2024;
Notification|Rejected|26/09/2023;
New application|CEP granted|04/04/2023
1409 Clenbuterol Hydrochloride VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2020-172 - Rev 02 2025/06/24 Valid 30/03/2027 Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Notification|Accepted - CEP remains valid|21/09/2023;
Notification|CEP granted|28/07/2022;
New application|CEP granted|30/03/2022
1431 Haloperidol decanoate MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2020-080 - Rev 03 2025/06/24 Valid 20/05/2027 Chemical 2025/06/24 Administrative procedure|CEP granted|24/06/2025;
Notification|CEP granted|06/06/2025;
Minor revision|Accepted - CEP remains valid|08/11/2024;
Major revision|CEP granted|30/08/2024;
New application|CEP granted|20/05/2022

数据库说明:

当前数据更新日期:2025年12月23日。
©2006-2025 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM