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
1559 Risperidone AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2024-147 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
42 Magnesium carbonate, light SCORA Caffiers FR 100017757;100026517 CEP 2024-058 - Rev 00 2025/07/11 Valid 11/07/2030 Chemical 2025/07/11 New application|CEP granted|11/07/2025
253 Ascorbic acid HEILONGJIANG NHU BIOTECHNOLOGY CO. LTD Suihua City CN 100047549;100078532 CEP 2023-349 - Rev 01 2025/07/10 Valid 19/11/2029 Chemical 2025/07/10 Minor revision|CEP granted|10/07/2025;
New application|CEP granted|19/11/2024
2780 Temozolomide FORMOSA LABORATORIES, INC. Taoyuan TW 100011879;100018688 CEP 2017-245 - Rev 02 2025/07/09 Valid Chemical 2025/07/09 Notification|CEP granted|09/07/2025;
Renewal|CEP granted|26/04/2024;
Notification|Accepted - CEP remains valid|07/07/2022
432 Rifamycin sodium EUROAPI ITALY S.R.L. Brindisi IT 100039217;100061735 CEP 2011-233 - Rev 04 2025/07/09 Valid Chemical 2025/07/09 Minor revision|CEP granted|09/07/2025;
Minor revision|Accepted - CEP remains valid|27/03/2025;
Notification|CEP granted|17/12/2021;
Notification|Accepted - CEP remains valid|04/08/2021;
Notification|CEP granted|09/11/2020
1004 Diltiazem hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1997-077 - Rev 16 2025/07/09 Valid Chemical 2025/09/16 Notification|Accepted - CEP remains valid|16/09/2025;
Minor revision|CEP granted|09/07/2025;
Notification|CEP granted|12/03/2025;
Notification|Accepted - CEP remains valid|10/10/2024;
Minor revision|CEP granted|13/12/2021;
Minor revision|CEP granted|25/09/2020
1472 Sodium hyaluronate, Intrinsic viscosity 2.93 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use KEWPIE CORP. Tokyo JP 100039277;100093553 CEP 2019-064 - Rev 01 2025/07/09 Valid Chemical and TSE 2025/07/09 Renewal|CEP granted|09/07/2025;
Minor revision|Accepted - CEP remains valid|01/12/2020
2330 Leflunomide FORMOSA LABORATORIES, INC. Taoyuan TW 100011879;100018688 CEP 2009-035 - Rev 03 2025/07/09 Valid Chemical 2025/07/09 Notification|CEP granted|09/07/2025;
Minor revision|CEP granted|12/05/2025
734 Prednisolone acetate, Micronised, sterile, alternative process FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2024-549 - Rev 00 2025/07/09 Valid 09/07/2030 Chemical 2025/07/09 New application|CEP granted|09/07/2025
3132 Mirabegron, α-Form MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2024-031 - Rev 00 2025/07/09 Valid 09/07/2030 Chemical 2025/07/09 New application|CEP granted|09/07/2025
2591 Celecoxib AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2019-112 - Rev 01 2025/07/09 Valid 09/04/2026 Chemical 2025/07/09 Minor revision|CEP granted|09/07/2025
2640 Atomoxetine hydrochloride, Process 2 COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2019-212 - Rev 03 2025/07/09 Valid Chemical 2025/07/09 Renewal|CEP granted|09/07/2025;
Notification|CEP granted|10/07/2024;
Notification|CEP granted|12/02/2021
929 Loperamide hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2008-313 - Rev 04 2025/07/08 Valid Chemical 2025/07/08 Notification|CEP granted|08/07/2025;
Minor revision|Accepted - CEP remains valid|19/06/2024;
Minor revision|Accepted - CEP remains valid|08/08/2022;
Notification|CEP granted|04/01/2022;
Notification|Accepted - CEP remains valid|02/02/2021
1538 Lovastatin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-406 - Rev 06 2025/07/08 Valid Chemical 2025/07/08 Administrative procedure|CEP granted|08/07/2025;
Minor revision|Accepted - CEP remains valid|09/05/2025;
Minor revision|Accepted - CEP remains valid|20/09/2022;
Notification|CEP granted|23/11/2021;
Monograph revision|CEP granted|09/08/2021;
Minor revision|Accepted - CEP remains valid|12/10/2020
2287 Fluconazole VIRUPAKSHA ORGANICS LIMITED Hyderabad IN 100021606;100076961 CEP 2009-364 - Rev 02 2025/07/08 Valid Chemical 2025/07/08 Major revision|CEP granted|08/07/2025;
Minor revision|CEP granted|18/09/2023
533 Triamcinolone acetonide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-084 - Rev 03 2025/07/08 Valid Chemical 2025/07/08 Notification|CEP granted|08/07/2025;
Notification|Accepted - CEP remains valid|05/08/2024;
Notification|Accepted - CEP remains valid|17/07/2023;
Minor revision|CEP granted|07/03/2022;
Minor revision|Accepted - CEP remains valid|31/03/2021
2640 Atomoxetine hydrochloride APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2014-241 - Rev 02 2025/07/08 Valid Chemical 2025/07/08 Minor revision|CEP granted|08/07/2025;
Notification|CEP granted|17/01/2024;
Renewal|CEP granted|21/01/2021
2372 Esomeprazole magnesium trihydrate LEE PHARMA LIMITED Hyderabad IN 100014849;100042625 CEP 2016-284 - Rev 01 2025/07/08 Valid Chemical 2025/07/08 Minor revision|CEP granted|08/07/2025;
Renewal|CEP granted|12/06/2023;
Major revision|CEP granted|16/01/2023
967 Acetylcysteine SEVEN STAR PHARMACEUTICAL COMPANY, LTD. New Taipei City TW 100024386;100033558 CEP 2022-177 - Rev 02 2025/07/08 Valid 29/08/2028 Chemical 2025/07/08 Major revision|CEP granted|08/07/2025;
Minor revision|CEP granted|01/08/2024;
New application|CEP granted|29/08/2023
2191 Atorvastatin calcium NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN 100030313;100047776 CEP 2019-013 - Rev 01 2025/07/08 Valid Chemical 2025/07/08 Renewal|CEP granted|08/07/2025;
Monograph revision|Accepted - CEP remains valid|19/07/2022

数据库说明:

当前数据更新日期:2025年12月22日。
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