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
1200 Dobutamine hydrochloride D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN 100023552;100032697 CEP 2023-369 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
1240 Mefenamic acid, Solara SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2025-076 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/12/22 Minor revision|Rejected|22/12/2025;
New application|CEP granted|09/05/2025
2778 Sitagliptin phosphate monohydrate, Process-II CHEMO SMS ENTERPRISE, SL Madrid ES 100038838;100060977 CEP 2025-049 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
2577 Oxcarbazepine, Code 1138 milled grade F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT 100011866;100022277 CEP 2025-115 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
2856 Pirfenidone SNJ LABS PRIVATE LIMITED Dist. Rajkot IN 100051266;100089774 CEP 2024-165 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
810 Betamethasone sodium phosphate HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2023-440 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
1096 Doxepin hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-197 - Rev 05 2025/05/07 Valid Chemical 2025/05/07 Minor revision|CEP granted|07/05/2025;
Minor revision|Accepted - CEP remains valid|26/06/2023;
Minor revision|CEP granted|08/12/2021;
Minor revision|Accepted - CEP remains valid|12/06/2020
1120 Lisinopril dihydrate RICHTER THEMIS MEDICARE (I) PVT. LTD. Vapi IN 100012132;100018972 CEP 2018-223 - Rev 01 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025
. Foetal Calf Serum, Defined, characterised, standard HYCLONE LABORATORIES LLC. Logan US 100012797;100022115 CEP 2000-076 - Rev 06 2025/05/07 Valid TSE 2025/05/07 Notification|CEP granted|07/05/2025;
Major revision|CEP granted|06/07/2022;
Notification|Rejected|25/03/2022;
Notification|Accepted - CEP remains valid|23/03/2021;
Notification|Accepted - CEP remains valid|27/08/2020;
Notification|CEP granted|24/06/2020
1705 Sertraline hydrochloride, Alternate process HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2012-218 - Rev 05 2025/05/07 Valid Chemical 2025/05/07 Minor revision|CEP granted|07/05/2025;
Minor revision|Accepted - CEP remains valid|04/10/2023;
Minor revision|Accepted - CEP remains valid|17/02/2023;
Minor revision|CEP granted|07/09/2022
816 Cinnarizine FLEMING LABORATORIES LIMITED Nawabpet Village IN 100015641;100024384 CEP 2015-019 - Rev 01 2025/05/07 Valid Chemical 2025/05/07 Monograph revision|CEP granted|07/05/2025;
Renewal|CEP granted|10/05/2022;
Minor revision|Accepted - CEP remains valid|03/02/2021
888 Ciprofloxacin Hydrochloride, Process 105 ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN 100022562;100093113 CEP 2019-007 - Rev 05 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025;
Minor revision|CEP granted|29/10/2024;
Minor revision|CEP granted|26/06/2023;
Minor revision|CEP granted|16/08/2024;
Notification|Rejected|23/01/2023;
Minor revision|CEP granted|01/08/2022
2849 Hydroxychloroquine sulfate MANGALAM DRUGS & ORGANICS LTD. Mumbai IN 100012477;100021137 CEP 2019-151 - Rev 02 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025;
Notification|CEP granted|19/07/2024
2600 Olmesartan medoxomil, Process II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2020-112 - Rev 04 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025;
Notification|CEP granted|11/01/2024;
Minor revision|CEP granted|05/06/2023;
Minor revision|CEP granted|19/08/2022;
New application|CEP granted|31/07/2020
1335 Itraconazole NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2011-283 - Rev 01 2025/05/05 Valid Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
Minor revision|Rejected|21/02/2025
2126 Cefepime dihydrochloride monohydrate, Sterile QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2011-286 - Rev 02 2025/05/05 Valid Chemical 2025/05/05 Major revision|CEP granted|05/05/2025;
Major revision|CEP granted|21/12/2021
2306 Gemcitabine hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2008-161 - Rev 03 2025/05/05 Valid Chemical 2025/05/05 Notification|CEP granted|05/05/2025;
Notification|CEP granted|20/12/2021;
Notification|Accepted - CEP remains valid|22/02/2021
394 Hydrochlorothiazide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2001-304 - Rev 13 2025/05/05 Valid Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
Notification|Accepted - CEP remains valid|20/02/2023;
Minor revision|CEP granted|03/10/2022;
Minor revision|CEP granted|01/12/2021;
Minor revision|CEP granted|09/12/2020
1058 Vancomycin hydrochloride CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN 100011996;100039007 CEP 2018-197 - Rev 01 2025/05/05 Valid Chemical and TSE 2025/05/05 Renewal|CEP granted|05/05/2025
1551 Nomegestrol acetate, Nomac grade B TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2014-178 - Rev 06 2025/05/05 Valid Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
Minor revision|CEP granted|25/09/2024;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|22/10/2021;
Minor revision|CEP granted|10/07/2020;
Monograph revision|CEP granted|06/05/2020

数据库说明:

当前数据更新日期:2026年02月10日。
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