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
372 Benzalkonium chloride HUBEI GEDIAN HUMANWELL PHARMACEUTICAL EXCIPIENTS CO. LTD. Ezhou City CN 100049221;100083387 CEP 2024-096 - Rev 00 2025/04/30 Valid 30/04/2030 Chemical 2025/04/30 New application|CEP granted|30/04/2025
2932 Rivaroxaban BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2023-085 - Rev 00 2025/04/30 Valid 30/04/2030 Chemical 2025/04/30 New application|CEP granted|30/04/2025
1012 Famotidine AZICO BIOPHORE INDIA PRIVATE LIMITED Hyderabad IN 100033325;100061652 CEP 2021-094 - Rev 02 2025/04/29 Valid 16/12/2027 Chemical 2025/04/29 Minor revision|CEP granted|29/04/2025;
Notification|CEP granted|26/05/2023;
New application|CEP granted|16/12/2022
1094 Cyproterone acetate, Micronised FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2018-270 - Rev 01 2025/04/29 Valid Chemical 2025/04/29 Renewal|CEP granted|29/04/2025
583 Lincomycin hydrochloride, Alternative process XINYU PHARMACEUTICAL CO., LTD. Suzhou City CN 100020532;100056331 CEP 2020-105 - Rev 02 2025/04/29 Valid Chemical 2025/04/29 Renewal|CEP granted|29/04/2025;
Notification|CEP granted|28/02/2024;
New application|CEP granted|10/07/2020
2416 Pramipexole dihydrochloride monohydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2010-328 - Rev 04 2025/04/29 Valid Chemical 2025/04/29 Notification|CEP granted|29/04/2025;
Minor revision|CEP granted|17/02/2023;
Minor revision|Accepted - CEP remains valid|11/08/2021
2931 Sorafenib tosilate SHANDONG LONCOM PHARMACEUTICAL CO., LTD Dezhou CN 100048642;100080616 CEP 2023-464 - Rev 00 2025/04/29 Valid 29/04/2030 Chemical 2025/04/29 New application|CEP granted|29/04/2025
1472 Sodium hyaluronate, GS-120, intrinsic viscosity: 1.7 m3/kg; from fermentation; for parenteral administration, including intra-ocular use KIKKOMAN BIOCHEMIFA COMPANY Noda City JP 100039417;100087689 CEP 2023-034 - Rev 02 2025/04/29 Valid 21/06/2028 Chemical 2025/04/29 Minor revision|CEP granted|29/04/2025;
Minor revision|CEP granted|30/04/2024;
New application|CEP granted|21/06/2023
2577 Oxcarbazepine, Process-II DASAMI LAB PRIVATE LIMITED Nalgonda IN 100033206;100051825 CEP 2023-348 - Rev 00 2025/04/29 Valid 29/04/2030 Chemical 2025/04/29 New application|CEP granted|29/04/2025
2930 Valganciclovir hydrochloride, Crystalline Type II OLON S.P.A. Rodano IT 100012085;100019537 CEP 2023-217 - Rev 00 2025/04/29 Valid 29/04/2030 Chemical 2025/09/03 Minor revision|Accepted - CEP remains valid|03/09/2025;
New application|CEP granted|29/04/2025
2733 Escitalopram oxalate, Process-IV NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2025-005 - Rev 01 2025/04/29 Valid 05/03/2030 Chemical 2025/04/29 Minor revision|CEP granted|29/04/2025;
New application|CEP granted|05/03/2025
2422 Oseltamivir phosphate, Form-A, route code OV MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN 100018316;100027671 CEP 2024-571 - Rev 00 2025/04/29 Valid 29/04/2030 Chemical 2025/04/29 New application|CEP granted|29/04/2025
2209 Sulbactam sodium, Sterile QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2024-030 - Rev 01 2025/04/29 Valid 14/03/2030 Chemical 2025/04/29 Administrative procedure|CEP granted|29/04/2025;
New application|CEP granted|14/03/2025
645 Tobramycin, Spray-dried, amorphous LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2024-023 - Rev 01 2025/04/29 Valid 25/06/2029 Chemical 2026/01/22 Monograph revision|Accepted - CEP remains valid|22/01/2026;
Notification|CEP granted|29/04/2025;
New application|CEP granted|25/06/2024
1489 Ambroxol hydrochloride, Process II AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN 100021822;100030527 CEP 2023-168 - Rev 01 2025/04/28 Valid 23/08/2028 Chemical 2025/04/28 Minor revision|CEP granted|28/04/2025;
New application|CEP granted|23/08/2023
2127 Clobetasol propionate CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2011-095 - Rev 02 2025/04/28 Valid Chemical 2025/04/28 Minor revision|CEP granted|28/04/2025;
Notification|CEP granted|25/08/2021
2133 Troxerutin TOPFOND PHARMACEUTICAL CO., LTD. Zhumadian CN 100023369;100077278 CEP 2023-419 - Rev 00 2025/04/28 Valid 28/04/2030 Chemical 2025/04/28 New application|CEP granted|28/04/2025
38 Levodopa SHANDONG LUKANG PHARMACEUTICAL CO., LTD. Jining City CN 100025471;100071013 CEP 2022-202 - Rev 00 2025/04/28 Valid 28/04/2030 Chemical and TSE 2025/04/28 New application|CEP granted|28/04/2025
2600 Olmesartan medoxomil CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN 100038839;100060978 CEP 2018-083 - Rev 04 2025/04/25 Valid Chemical 2025/04/25 Renewal|CEP granted|25/04/2025;
Minor revision|CEP granted|03/08/2023;
Notification|Accepted - CEP remains valid|06/01/2023;
Minor revision|Accepted - CEP remains valid|21/12/2022;
Minor revision|CEP granted|06/09/2022;
Monograph revision|CEP granted|06/05/2022
2017 Oxaliplatin, Process HER-2 HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE 100012310;100021629 CEP 2006-137 - Rev 06 2025/04/25 Valid Chemical 2025/04/25 Notification|CEP granted|25/04/2025;
Notification|CEP granted|02/10/2023;
Notification|CEP granted|18/07/2022;
Notification|CEP granted|24/03/2021

数据库说明:

当前数据更新日期:2026年02月10日。
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