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
2234 Meropenem trihydrate, Sterile, synthetic origin, process II SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2018-268 - Rev 02 2025/10/28 Valid Chemical 2025/10/28 Renewal|CEP granted|28/10/2025;
Minor revision|CEP granted|19/12/2022
2179 Pimobendan for Veterinary Use WISDOM PHARMACEUTICAL CO., LTD. Haimen CN 100014837;100023467 CEP 2013-329 - Rev 01 2025/10/27 Valid Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
Minor revision|Accepted - CEP remains valid|29/06/2021;
Renewal|CEP granted|03/05/2021;
Minor revision|Accepted - CEP remains valid|30/10/2020
1961 Poly(vinyl alcohol), Viscosity 5.1 mPa.s, Ester value 140 mg KOH/g MITSUBISHI CHEMICAL CORPORATION Chiyoda JP 100047136;100077835 CEP 2013-209 - Rev 01 2025/10/27 Valid Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
Renewal|CEP granted|28/09/2021;
Administrative procedure|CEP granted|13/01/2020
977 Brompheniramine maleate SUPRIYA LIFESCIENCE LIMITED Mumbai IN 100015796;100024574 CEP 2015-097 - Rev 02 2025/10/27 Valid Chemical 2025/10/27 Administrative procedure|CEP granted|27/10/2025;
Major revision|CEP granted|14/05/2025;
Renewal|CEP granted|19/01/2023
2191 Atorvastatin calcium, Form-I LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2021-150 - Rev 02 2025/10/27 Valid 18/01/2028 Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
Minor revision|Accepted - CEP remains valid|28/06/2024;
Administrative procedure|CEP granted|28/03/2023;
New application|CEP granted|19/01/2023
2631 Rosuvastatin calcium, RS02 CTX LIFESCIENCES PVT. LIMITED Surat IN 100019102;100027863 CEP 2025-419 - Rev 00 2025/10/27 Valid 27/10/2030 Chemical 2025/10/27 New application|CEP granted|27/10/2025
2230 Latanoprost FDC Limited Mumbai IN 100011646;100021030 CEP 2024-162 - Rev 01 2025/10/27 Valid 17/09/2030 Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
New application|CEP granted|17/09/2025
2778 Sitagliptin phosphate monohydrate IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN 100017919;100037377 CEP 2024-063 - Rev 00 2025/10/27 Valid 27/10/2030 Chemical 2025/10/27 New application|CEP granted|27/10/2025
2449 Docetaxel trihydrate HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2022-149 - Rev 02 2025/10/27 Valid 07/03/2029 Chemical 2025/10/27 Minor revision|CEP granted|27/10/2025;
Minor revision|CEP granted|15/11/2024;
New application|CEP granted|07/03/2024
1656 Moxidectin for veterinary use, with butyl hydroxytoluene HISUN PHARMACEUTICAL (HANGZHOU) CO., LTD. Hangzhou City CN 100012542;100060684 CEP 2012-384 - Rev 03 2025/10/24 Valid Chemical 2025/10/24 Minor revision|CEP granted|24/10/2025;
Minor revision|CEP granted|13/12/2021
1794 Paclitaxel, Produced by a semi-synthetic process CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN 100041836;100068984 CEP 2022-006 - Rev 01 2025/10/24 Valid 07/02/2028 Chemical 2025/10/24 Minor revision|CEP granted|24/10/2025;
New application|CEP granted|07/02/2023
2420 Tiotropium bromide monohydrate, Micronised, non-micronised Inke, S.A. Castellbisbal ES 100020253;100029013 CEP 2019-337 - Rev 02 2025/10/24 Valid Chemical 2025/10/24 Renewal|CEP granted|24/10/2025;
Minor revision|CEP granted|16/05/2023
1524 Gliclazide SHANDONG HAIYOU FREDA PHARMACEUTICAL CO. LTD. Linyi CN 100043655;100072192 CEP 2024-434 - Rev 00 2025/10/24 Valid 24/10/2030 Chemical 2025/10/24 New application|CEP granted|24/10/2025
2604 Ropinirole hydrochloride DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2021-240 - Rev 01 2025/10/22 Valid 31/10/2029 Chemical 2025/10/22 Major revision|CEP granted|22/10/2025;
New application|CEP granted|31/10/2024
1768 Valaciclovir hydrochloride, Process B ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN 100011826;100018693 CEP 2024-169 - Rev 02 2025/10/22 Valid 25/09/2029 Chemical 2025/10/22 Administrative procedure|CEP granted|22/10/2025;
Minor revision|CEP granted|08/10/2025;
New application|CEP granted|25/09/2024
3087 Ticagrelor Zhejiang Supor Pharmaceuticals Co., Ltd. Shaoxing CN 100022886;100031604 CEP 2023-374 - Rev 00 2025/10/22 Valid 22/10/2030 Chemical 2025/10/22 New application|CEP granted|22/10/2025
1002 Diclofenac sodium HENAN DONGTAI PHARM CO., LTD. Anyang CN 100023192;100052097 CEP 2014-009 - Rev 01 2025/10/22 Valid Chemical 2025/10/22 Major revision|CEP granted|22/10/2025;
Renewal|CEP granted|21/12/2020;
Major revision|CEP granted|03/06/2020
2217 Lamivudine, SVL Process MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2014-034 - Rev 05 2025/10/22 Valid Chemical 2025/10/22 Notification|CEP granted|22/10/2025;
Transfer of holdership|CEP granted|25/07/2024;
Minor revision|CEP granted|28/03/2024;
Minor revision|CEP granted|30/08/2022;
Major revision|CEP granted|16/11/2020
1508 Diclofenac potassium HENAN DONGTAI PHARM CO., LTD. Anyang CN 100023192;100052097 CEP 2014-031 - Rev 01 2025/10/22 Valid Chemical 2025/10/22 Major revision|CEP granted|22/10/2025;
Renewal|CEP granted|08/03/2021;
Major revision|CEP granted|03/06/2020
2757 Aprepitant WISDOM PHARMACEUTICAL CO., LTD. Haimen CN 100014837;100023467 CEP 2019-117 - Rev 01 2025/10/22 Valid Chemical 2025/10/22 Renewal|CEP granted|22/10/2025

数据库说明:

当前数据更新日期:2025年12月14日。
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