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
141 Ethionamide APICHEM LABORATORIES PRIVATE LIMITED Yadadri Bhuvanagiri District IN 100049373;100087707 CEP 2024-502 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2577 Oxcarbazepine ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100033956;100079880 CEP 2024-343 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2288 Citalopram hydrobromide, Sulfuric Acid Process, Micronised and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2025-004 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
. Glutaraldehyde fixed bovine pericardium MERIL LIFE SCIENCES PRIVATE LIMITED Vapi IN 100054083;100095677 CEP 2024-425 - Rev 00 2025/04/25 Valid 25/04/2030 TSE 2025/04/25 New application|CEP granted|25/04/2025
2775 Nebivolol hydrochloride, Micronised F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT 100011866;100022277 CEP 2024-214 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2244 Tacrolimus monohydrate CONCORD BIOTECH LIMITED Ahmedabad IN 100005519;100000897 CEP 2018-216 - Rev 01 2025/04/25 Valid Chemical 2025/04/25 Renewal|CEP granted|25/04/2025
1183 Calcium dobesilate monohydrate BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2023-106 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2933 Deferasirox AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2021-176 - Rev 01 2025/04/25 Valid 23/10/2028 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
New application|CEP granted|23/10/2023
2778 Sitagliptin phosphate monohydrate, (1466) MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2023-205 - Rev 01 2025/04/25 Valid 12/02/2029 Chemical 2025/04/25 Notification|CEP granted|25/04/2025;
New application|CEP granted|12/02/2024
2191 Atorvastatin calcium, 317500 KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2023-270 - Rev 03 2025/04/25 Valid 24/01/2029 Chemical 2025/04/25 Administrative procedure|CEP granted|25/04/2025;
Minor revision|CEP granted|08/04/2025;
Administrative procedure|CEP granted|06/02/2024;
New application|CEP granted|24/01/2024
1088 Cinchocaine Hydrochloride, Micronised and non-micronised PHARMASYNTHESE Saint Pierre Les Elbeuf FR 100012546;100020952 CEP 2007-117 - Rev 03 2025/04/16 Valid Chemical 2025/08/01 Minor revision|Accepted - CEP remains valid|01/08/2025;
Notification|CEP granted|16/04/2025;
Minor revision|CEP granted|23/02/2023
309 Acetylsalicylic acid The Andhra Sugars Limited Tanuku IN 100021433;100030128 CEP 2000-042 - Rev 05 2025/04/16 Valid Chemical 2025/04/16 Minor revision|CEP granted|16/04/2025;
Minor revision|CEP granted|20/04/2021
1734 Terbinafine hydrochloride SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN 100014777;100050265 CEP 2007-279 - Rev 06 2025/04/16 Valid Chemical 2025/04/16 Minor revision|CEP granted|16/04/2025;
Notification|CEP granted|17/02/2020
1378 Valproic acid SCI PHARMTECH, INC. Taoyuan City TW 100017752;100052419 CEP 2003-108 - Rev 06 2025/04/16 Valid Chemical 2025/04/16 Minor revision|CEP granted|16/04/2025;
Minor revision|Accepted - CEP remains valid|28/10/2022
1322 Fenofibrate, Non-micronised, micronised HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2008-023 - Rev 05 2025/04/16 Valid Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
Minor revision|CEP granted|09/02/2024;
Minor revision|Accepted - CEP remains valid|27/05/2021
408 Methadone hydrochloride HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2011-086 - Rev 01 2025/04/16 Valid Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
Minor revision|Accepted - CEP remains valid|06/02/2023
727 Lidocaine HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2014-234 - Rev 02 2025/04/16 Valid Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
Minor revision|CEP granted|03/04/2024;
Minor revision|Accepted - CEP remains valid|24/03/2023;
Renewal|CEP granted|08/07/2021
1002 Diclofenac sodium OLON S.P.A. Rodano IT 100012085;100019537 CEP 2009-303 - Rev 05 2025/04/16 Valid Chemical 2025/04/16 Minor revision|CEP granted|16/04/2025;
Minor revision|Accepted - CEP remains valid|30/06/2023;
Minor revision|CEP granted|01/06/2021;
Minor revision|CEP granted|28/01/2021
1378 Valproic acid HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2015-158 - Rev 02 2025/04/16 Valid Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
Minor revision|CEP granted|05/04/2024;
Renewal|CEP granted|31/05/2022
227 Lidocaine hydrochloride monohydrate HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2015-044 - Rev 01 2025/04/16 Valid Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
Renewal|CEP granted|12/07/2021;
Minor revision|CEP granted|14/04/2021

数据库说明:

当前数据更新日期:2026年02月10日。
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