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
412 Sodium citrate dihydrate JUNGBUNZLAUER LADENBURG GMBH Ladenburg DE 100014785;100073136 CEP 2018-273 - Rev 06 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Renewal|CEP granted|21/10/2024;
Notification|CEP granted|21/06/2024;
Notification|Accepted - CEP remains valid|24/08/2023;
Minor revision|CEP granted|01/09/2022;
Minor revision|CEP granted|09/06/2021;
Minor revision|CEP granted|04/06/2020
1520 Foscarnet sodium hexahydrate LIANYUNGANG RUNZHONG PHARMACEUTICAL CO., LTD. Lianyungang CN 100019457;100028232 CEP 2017-137 - Rev 01 2025/07/11 Valid Chemical 2025/07/11 Minor revision|CEP granted|11/07/2025;
Notification|Accepted - CEP remains valid|24/06/2024;
Renewal|CEP granted|27/07/2023;
Minor revision|Accepted - CEP remains valid|08/03/2022;
Notification|Accepted - CEP remains valid|11/01/2022;
Minor revision|Accepted - CEP remains valid|23/11/2020
2931 Sorafenib tosilate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2021-247 - Rev 02 2025/07/11 Valid 10/07/2028 Chemical 2025/07/11 Monograph revision|CEP granted|11/07/2025;
Minor revision|CEP granted|23/04/2024;
New application|CEP granted|10/07/2023
883 Calcitriol, Process 2 (F007V1) FORMOSA LABORATORIES, INC. Taoyuan TW 100011879;100018688 CEP 2020-150 - Rev 03 2025/07/11 Valid 22/10/2026 Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Monograph revision|CEP granted|18/12/2024;
Administrative procedure|CEP granted|18/11/2021;
New application|CEP granted|22/10/2021
1472 Sodium hyaluronate, GS-200; intrinsic viscosity 2.77 m3/kg; from fermentation; for parenteral administration, including intra-ocular use KIKKOMAN BIOCHEMIFA CO. Noda City JP 100039417;100087689 CEP 2020-138 - Rev 01 2025/07/11 Valid Chemical 2025/07/11 Renewal|CEP granted|11/07/2025;
Notification|Accepted - CEP remains valid|03/05/2024;
New application|CEP granted|28/08/2020
72 Cholecalciferol, Site Sisseln DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2019-351 - Rev 02 2025/07/11 Valid Chemical and TSE 2025/11/26 Notification|Accepted - CEP remains valid|26/11/2025;
Notification|CEP granted|11/07/2025;
Renewal|CEP granted|14/03/2025
2777 Pregabalin DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2020-024 - Rev 03 2025/07/11 Valid 03/02/2027 Chemical 2025/07/11 Minor revision|CEP granted|11/07/2025;
Minor revision|CEP granted|19/06/2024;
Major revision|CEP granted|16/09/2022;
New application|CEP granted|03/02/2022
2631 Rosuvastatin calcium CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL 100002351;100005259 CEP 2015-090 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Minor revision|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|21/12/2023;
Minor revision|Accepted - CEP remains valid|02/05/2023;
Minor revision|CEP granted|20/04/2022;
Minor revision|Rejected|02/03/2022;
Renewal|CEP granted|01/07/2021;
Monograph revision|Accepted - CEP remains valid|27/05/2020
2759 Benzydamine hydrochloride BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2021-325 - Rev 02 2025/07/11 Valid 12/04/2029 Chemical 2025/07/11 Minor revision|CEP granted|11/07/2025;
Administrative procedure|CEP granted|05/06/2024;
New application|CEP granted|12/04/2024
2594 Duloxetine hydrochloride, Process-K APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-273 - Rev 01 2025/07/11 Valid 22/10/2029 Chemical 2025/07/11 Minor revision|CEP granted|11/07/2025;
New application|CEP granted|22/10/2024
2288 Citalopram hydrobromide CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2009-012 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Minor revision|CEP granted|11/07/2025
203 Polymyxin B sulfate North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN 100021261;100029965 CEP 2024-323 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
1182 Calcium ascorbate dihydrate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2002-253 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|CEP granted|19/03/2024;
Monograph revision|Accepted - CEP remains valid|03/08/2023
1069 Betacarotene DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2010-383 - Rev 02 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025
1559 Risperidone TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-110 - Rev 06 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Minor revision|CEP granted|02/05/2023;
Notification|CEP granted|23/02/2022;
Minor revision|CEP granted|03/09/2020
1046 Tamoxifen citrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-180 - Rev 07 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Notification|CEP granted|21/12/2021;
Notification|CEP granted|07/12/2020
761 Dexpanthenol DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1997-113 - Rev 04 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Monograph revision|CEP granted|22/04/2021
543 Carbamazepine TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-164 - Rev 06 2025/07/11 Valid Chemical 2025/07/11 Notification|CEP granted|11/07/2025;
Notification|CEP granted|21/12/2021
1745 Carvedilol TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-048 - Rev 07 2025/07/11 Valid Chemical 2025/12/11 Notification|Accepted - CEP remains valid|11/12/2025;
Notification|CEP granted|11/07/2025;
Notification|CEP granted|23/02/2022;
Notification|CEP granted|19/10/2020
574 Cholecalciferol concentrate (powder form), 100 000 IU/g, with all-rac-α-tocopherol DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2015-199 - Rev 01 2025/07/11 Valid Chemical and TSE 2025/11/27 Notification|Accepted - CEP remains valid|27/11/2025;
Notification|CEP granted|11/07/2025;
Renewal|CEP granted|03/09/2021;
Minor revision|CEP granted|13/08/2020

数据库说明:

当前数据更新日期:2025年12月22日。
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