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
1104 Fluoxetine hydrochloride IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2023-400 - Rev 00 2025/04/08 Valid 08/04/2030 Chemical 2025/04/08 New application|CEP granted|08/04/2025
2777 Pregabalin ENANTI LABS PRIVATE LIMITED Anakapalli District IN 100047758;100078940 CEP 2023-199 - Rev 00 2025/04/08 Valid 08/04/2030 Chemical 2025/04/08 New application|CEP granted|08/04/2025
2423 Valsartan CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN 100048075;100079517 CEP 2023-282 - Rev 00 2025/04/08 Valid 08/04/2030 Chemical 2025/04/08 New application|CEP granted|08/04/2025
2196 Bicalutamide, Form-H1 HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2012-254 - Rev 03 2025/04/07 Valid Chemical 2025/04/07 Minor revision|CEP granted|07/04/2025;
Minor revision|Accepted - CEP remains valid|11/08/2023;
Minor revision|CEP granted|09/01/2023;
Minor revision|Accepted - CEP remains valid|16/03/2022;
Notification|Rejected|17/01/2022;
Minor revision|CEP granted|29/06/2020
2787 Esomeprazole magnesium dihydrate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2014-258 - Rev 03 2025/04/07 Valid Chemical 2025/04/07 Notification|CEP granted|07/04/2025;
Minor revision|Accepted - CEP remains valid|26/02/2024;
Minor revision|CEP granted|09/02/2023;
Notification|CEP granted|06/12/2022;
Renewal|CEP granted|02/12/2020;
Minor revision|CEP granted|24/06/2020
2017 Oxaliplatin, Process HER-1 HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE 100012310;100021629 CEP 2003-278 - Rev 09 2025/04/07 Valid Chemical 2025/04/07 Notification|CEP granted|07/04/2025;
Notification|CEP granted|02/10/2023;
Notification|CEP granted|07/07/2022;
Notification|Accepted - CEP remains valid|03/06/2021;
Minor revision|CEP granted|26/03/2021
816 Cinnarizine FDC Limited Mumbai IN 100011646;100021030 CEP 2003-150 - Rev 04 2025/04/07 Valid Chemical 2025/04/07 Monograph revision|CEP granted|07/04/2025;
Minor revision|CEP granted|08/09/2023;
Minor revision|Accepted - CEP remains valid|21/07/2022
2856 Pirfenidone, micronised, non-micronised SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2016-242 - Rev 01 2025/04/07 Valid Chemical 2025/04/07 Minor revision|CEP granted|07/04/2025;
Renewal|CEP granted|03/10/2022;
Minor revision|CEP granted|20/08/2021
1722 Flunarizine dihydrochloride VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2020-224 - Rev 04 2025/04/07 Valid 01/02/2027 Chemical 2025/04/07 Minor revision|CEP granted|07/04/2025;
Monograph revision|CEP granted|18/08/2023;
Notification|CEP granted|03/02/2023;
Minor revision|CEP granted|06/07/2022;
New application|CEP granted|01/02/2022
19 Quinine sulfate PT. SINKONA INDONESIA LESTARI Subang ID 100015420;100024139 CEP 2024-412 - Rev 00 2025/04/07 Valid 07/04/2030 Chemical 2025/04/07 New application|CEP granted|07/04/2025
227 Lidocaine hydrochloride monohydrate CHEMINO PHARMA LIMITED Mumbai IN 100049314;100083804 CEP 2021-084 - Rev 01 2025/04/07 Valid 14/08/2029 Chemical 2025/04/07 Minor revision|CEP granted|07/04/2025;
New application|CEP granted|14/08/2024
2857 Trazodone hydrochloride, Milled, Unmilled INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2024-228 - Rev 00 2025/04/07 Valid 07/04/2030 Chemical 2025/04/07 New application|CEP granted|07/04/2025
2856 Pirfenidone AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2019-067 - Rev 02 2025/04/07 Valid Chemical 2025/04/07 Renewal|CEP granted|07/04/2025;
Minor revision|CEP granted|11/09/2024;
Minor revision|Accepted - CEP remains valid|22/05/2023;
Notification|Rejected|20/03/2023
1104 Fluoxetine hydrochloride NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2023-372 - Rev 00 2025/04/07 Valid 07/04/2030 Chemical 2025/04/07 New application|CEP granted|07/04/2025
2631 Rosuvastatin calcium ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2016-175 - Rev 01 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Renewal|CEP granted|26/04/2023;
Notification|CEP granted|06/12/2022;
Major revision|CEP granted|24/06/2022;
Major revision|Rejected|27/08/2021;
Monograph revision|Accepted - CEP remains valid|24/08/2020
2631 Rosuvastatin calcium, D518 Process ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2021-265 - Rev 02 2025/04/04 Valid 05/01/2027 Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
New application|CEP granted|05/01/2022
2585 Rizatriptan benzoate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2012-108 - Rev 03 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
Minor revision|CEP granted|07/01/2022
2856 Pirfenidone ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2017-170 - Rev 04 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Renewal|CEP granted|15/04/2024;
Notification|CEP granted|05/12/2022
2019 Perindopril tert-butylamine ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2004-279 - Rev 06 2025/04/04 Valid Chemical 2025/04/04 Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
Monograph revision|Accepted - CEP remains valid|09/04/2020
228 Lithium carbonate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2023-190 - Rev 01 2025/04/04 Valid 11/01/2029 Chemical 2025/11/04 Notification|Accepted - CEP remains valid|04/11/2025;
Notification|CEP granted|04/04/2025;
New application|CEP granted|11/01/2024

数据库说明:

当前数据更新日期:2026年03月22日。
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