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
2775 Nebivolol hydrochloride, Crystalline, micronised and non-micronised MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN 100014794;100023345 CEP 2022-193 - Rev 02 2025/04/14 Valid 16/08/2028 Chemical 2025/04/14 Minor revision|CEP granted|14/04/2025;
Minor revision|CEP granted|13/03/2024;
New application|CEP granted|16/08/2023
1712 Carboprost trometamol CHIROGATE INTERNATIONAL INC. Taoyuan City TW 100014759;100023286 CEP 2023-336 - Rev 00 2025/04/14 Valid 14/04/2030 Chemical 2025/04/14 New application|CEP granted|14/04/2025
3087 Ticagrelor SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2023-397 - Rev 00 2025/04/14 Valid 14/04/2030 Chemical 2025/11/06 Minor revision|Accepted - CEP remains valid|06/11/2025;
New application|CEP granted|14/04/2025
1651 Clarithromycin, Code 128 ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN 100022562;100093113 CEP 2019-033 - Rev 02 2025/04/14 Valid Chemical 2025/04/14 Renewal|CEP granted|14/04/2025;
Notification|Accepted - CEP remains valid|05/06/2024;
Minor revision|CEP granted|06/10/2022
1482 Zinc acetate dihydrate CHONGQING MIDECO PHARMACEUTICAL CO., LTD. Jinfeng Town CN 100051107;100089458 CEP 2024-197 - Rev 00 2025/04/14 Valid 14/04/2030 Chemical 2025/04/14 New application|CEP granted|14/04/2025
3036 Teriflunomide HONOUR LAB LIMITED Hyderabad IN 100011891;100022136 CEP 2023-422 - Rev 00 2025/04/11 Valid 11/04/2030 Chemical 2025/04/11 New application|CEP granted|11/04/2025
3132 Mirabegron MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2023-308 - Rev 00 2025/04/11 Valid 11/04/2030 Chemical 2025/04/11 New application|CEP granted|11/04/2025
1798 Trospium chloride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2010-040 - Rev 04 2025/04/11 Valid Chemical 2025/04/11 Notification|CEP granted|11/04/2025;
Minor revision|Accepted - CEP remains valid|30/06/2023;
Notification|CEP granted|02/12/2022;
Minor revision|Accepted - CEP remains valid|25/03/2021;
Minor revision|Accepted - CEP remains valid|18/08/2020
562 Sodium cromoglicate AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2024-052 - Rev 00 2025/04/11 Valid 11/04/2030 Chemical 2025/04/11 New application|CEP granted|11/04/2025
2576 Voriconazole, Process-II LEE PHARMA LIMITED Hyderabad IN 100014849;100042625 CEP 2024-403 - Rev 01 2025/04/11 Valid 19/02/2030 Chemical 2025/04/11 Notification|CEP granted|11/04/2025;
New application|CEP granted|19/02/2025
1181 Buprenorphine hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2009-312 - Rev 01 2025/04/11 Valid Chemical 2025/04/11 Minor revision|CEP granted|11/04/2025
2631 Rosuvastatin calcium, Process III ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2022-377 - Rev 01 2025/04/10 Valid 21/02/2028 Chemical 2025/04/10 Notification|CEP granted|10/04/2025;
New application|CEP granted|21/02/2023
2154 Telmisartan, Process III ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2024-184 - Rev 01 2025/04/10 Valid 29/08/2029 Chemical 2025/04/10 Notification|CEP granted|10/04/2025;
New application|CEP granted|29/08/2024
2631 Rosuvastatin calcium, Process IV ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2024-290 - Rev 01 2025/04/10 Valid 17/01/2030 Chemical 2025/04/10 Notification|CEP granted|10/04/2025;
New application|CEP granted|17/01/2025
3132 Mirabegron, Micronised and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2023-249 - Rev 00 2025/04/10 Valid 10/04/2030 Chemical 2025/04/10 New application|CEP granted|10/04/2025
2064 Chondroitin sulfate sodium, Terrestrial porcine origin BIOIBERICA, S.A.U. Palafolls ES 100000136;100043853 CEP 2024-106 - Rev 01 2025/04/10 Valid 14/05/2029 Chemical 2025/04/10 Minor revision|CEP granted|10/04/2025;
New application|CEP granted|14/05/2024
3087 Ticagrelor ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2022-128 - Rev 01 2025/04/10 Valid 03/07/2029 Chemical 2025/04/10 Notification|CEP granted|10/04/2025;
New application|CEP granted|03/07/2024
2154 Telmisartan, Process II ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2022-047 - Rev 02 2025/04/10 Valid 13/05/2027 Chemical 2025/04/10 Notification|CEP granted|10/04/2025;
Minor revision|CEP granted|16/01/2023;
New application|CEP granted|13/05/2022
2173 Gabapentin, Process II JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN 100020812;100080065 CEP 2019-343 - Rev 03 2025/04/10 Valid Chemical 2026/01/23 Minor revision|Accepted - CEP remains valid|23/01/2026;
Minor revision|CEP granted|10/04/2025;
Renewal|CEP granted|24/02/2025;
Minor revision|CEP granted|16/02/2023;
Minor revision|Accepted - CEP remains valid|28/04/2022;
Minor revision|Accepted - CEP remains valid|23/11/2021
1734 Terbinafine hydrochloride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2007-316 - Rev 04 2025/04/10 Valid Chemical 2025/04/10 Notification|CEP granted|10/04/2025;
Notification|CEP granted|02/12/2022

数据库说明:

当前数据更新日期:2026年02月10日。
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