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
944 Piroxicam ARCH PHARMALABS LIMITED Mumbai IN 100011823;100095249 CEP 2000-034 - Rev 12 2025/02/26 Valid Chemical 2025/02/26 Notification|CEP granted|26/02/2025;
Minor revision|CEP granted|01/02/2024;
Notification|CEP granted|04/12/2023;
Minor revision|Accepted - CEP remains valid|18/09/2023;
Major revision|CEP granted|22/07/2022;
Notification|Rejected|25/04/2022
2182 Trimebutine maleate ZACH SYSTEM Avrillé FR 100012282;100021396 CEP 2013-207 - Rev 01 2025/02/26 Valid Chemical 2025/02/26 Minor revision|CEP granted|26/02/2025;
Minor revision|Accepted - CEP remains valid|17/10/2023;
Notification|Rejected|30/11/2022;
Notification|Accepted - CEP remains valid|26/06/2020
2606 Tadalafil ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2011-316 - Rev 01 2025/02/26 Valid Chemical 2025/02/26 Minor revision|CEP granted|26/02/2025;
Minor revision|Accepted - CEP remains valid|19/12/2024;
Minor revision|Accepted - CEP remains valid|08/01/2024;
Notification|Accepted - CEP remains valid|23/02/2023;
Minor revision|Accepted - CEP remains valid|30/10/2020
2217 Lamivudine, Process 1 LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2019-133 - Rev 03 2025/02/26 Valid Chemical 2025/02/26 Renewal|CEP granted|26/02/2025;
Notification|CEP granted|25/01/2023;
Major revision|CEP granted|29/08/2022
986 Cefaclor Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan CN 100033695;100052910 CEP 2018-052 - Rev 01 2025/02/26 Valid Chemical 2025/02/26 Renewal|CEP granted|26/02/2025
454 Acetazolamide EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022690 CEP 2018-203 - Rev 02 2025/02/26 Valid Chemical 2025/02/26 Renewal|CEP granted|26/02/2025;
Minor revision|CEP granted|27/11/2023;
Minor revision|Accepted - CEP remains valid|13/01/2022
1104 Fluoxetine hydrochloride, Process II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2019-226 - Rev 04 2025/02/26 Valid Chemical 2025/02/26 Renewal|CEP granted|26/02/2025;
Notification|CEP granted|16/11/2023;
Minor revision|Accepted - CEP remains valid|29/06/2023;
Notification|Accepted - CEP remains valid|13/12/2021;
Administrative procedure|CEP granted|12/03/2021;
Monograph revision|CEP granted|03/03/2021
2591 Celecoxib, Process-IV MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2022-201 - Rev 01 2025/02/26 Valid 19/08/2027 Chemical 2025/02/26 Minor revision|CEP granted|26/02/2025;
New application|CEP granted|19/08/2022
1012 Famotidine, Form B APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2023-307 - Rev 00 2025/02/26 Valid 26/02/2030 Chemical 2025/02/26 New application|CEP granted|26/02/2025
1449 Mometasone furoate HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2024-339 - Rev 00 2025/02/26 Valid 26/02/2030 Chemical 2025/02/26 New application|CEP granted|26/02/2025
2930 Valganciclovir hydrochloride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2022-398 - Rev 01 2025/02/26 Valid 14/02/2029 Chemical 2025/02/26 Minor revision|CEP granted|26/02/2025;
New application|CEP granted|14/02/2024
2583 Montelukast sodium, 1556 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2024-390 - Rev 00 2025/02/26 Valid 26/02/2030 Chemical 2025/02/26 New application|CEP granted|26/02/2025
811 Betamethasone valerate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-095 - Rev 05 2025/02/26 Valid Chemical 2025/02/26 Notification|CEP granted|26/02/2025;
Minor revision|Accepted - CEP remains valid|22/01/2024;
Notification|Rejected|25/09/2023;
Notification|CEP granted|25/11/2021;
Notification|Accepted - CEP remains valid|08/09/2021;
Notification|Accepted - CEP remains valid|10/07/2020
890 Clonazepam R L FINE CHEM PVT. LTD. Bengaluru IN 100016723;100067511 CEP 2023-053 - Rev 00 2025/02/26 Valid 26/02/2030 Chemical 2025/02/26 New application|CEP granted|26/02/2025
755 Carbidopa TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2002-052 - Rev 09 2025/02/25 Valid Chemical 2025/02/25 Notification|CEP granted|25/02/2025;
Notification|CEP granted|23/11/2022;
Notification|Accepted - CEP remains valid|04/02/2022;
Notification|CEP granted|05/01/2022;
Minor revision|CEP granted|10/03/2021
1489 Ambroxol hydrochloride SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2004-201 - Rev 06 2025/02/25 Valid Chemical 2025/02/25 Minor revision|CEP granted|25/02/2025;
Notification|CEP granted|20/07/2022;
Minor revision|Accepted - CEP remains valid|12/05/2022;
Notification|CEP granted|02/03/2020
1146 Roxithromycin ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 1999-029 - Rev 11 2025/02/25 Valid Chemical 2025/02/25 Administrative procedure|CEP granted|25/02/2025;
Minor revision|CEP granted|13/02/2025;
Minor revision|Accepted - CEP remains valid|23/11/2020
1002 Diclofenac sodium ARCH PHARMALABS LIMITED Mumbai IN 100011823;100095249 CEP 2002-022 - Rev 07 2025/02/25 Valid Chemical 2025/02/25 Notification|CEP granted|25/02/2025;
Notification|CEP granted|04/12/2023;
Notification|CEP granted|25/02/2021
2071 Milk thistle dry extract, refined and standardised, DER: 22-27:1 TAPI CZECH INDUSTRIES S.R.O. Opava CZ 100051642;100090678 CEP 2008-237 - Rev 07 2025/02/25 Valid Herbal 2025/02/25 Administrative procedure|CEP granted|25/02/2025;
Notification|CEP granted|17/02/2025;
Notification|CEP granted|11/09/2024;
Monograph revision|Accepted - CEP remains valid|15/03/2024;
Minor revision|CEP granted|02/07/2021;
Minor revision|CEP granted|08/07/2020
2631 Rosuvastatin calcium, Route code "RT", Amorphous Form, Micronised and Non-micronised MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2015-274 - Rev 01 2025/02/25 Valid Chemical 2025/02/25 Minor revision|CEP granted|25/02/2025;
Renewal|CEP granted|24/11/2021;
Minor revision|CEP granted|28/01/2021;
Monograph revision|Accepted - CEP remains valid|15/04/2020

数据库说明:

当前数据更新日期:2025年12月08日。
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