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
2015 Ebastine MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2009-106 - Rev 04 2025/05/13 Valid Chemical 2025/05/13 Minor revision|CEP granted|13/05/2025;
Minor revision|CEP granted|13/07/2023
2733 Escitalopram oxalate, Process I HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2016-306 - Rev 01 2025/05/13 Valid Chemical 2025/05/13 Minor revision|CEP granted|13/05/2025;
Renewal|CEP granted|23/05/2023;
Minor revision|CEP granted|28/10/2020
2778 Sitagliptin phosphate monohydrate MOREPEN LABORATORIES LIMITED Baddi IN 100017843;100026642 CEP 2019-040 - Rev 01 2025/05/13 Valid Chemical 2025/05/13 Renewal|CEP granted|13/05/2025
1710 Bisoprolol fumarate MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN 100023732;100032901 CEP 2018-209 - Rev 01 2025/05/13 Valid Chemical 2025/05/13 Renewal|CEP granted|13/05/2025
2740 Sodium selenite RETORTE GMBH SELENIUM CHEMICALS & METALS Röthenbach DE 100026545;100042398 CEP 2018-129 - Rev 02 2025/05/13 Valid Chemical 2025/05/13 Minor revision|CEP granted|13/05/2025;
Renewal|CEP granted|15/02/2024
2782 Vardenafil hydrochloride trihydrate SMS PHARMACEUTICALS LIMITED Hyderabad IN 100011780;100061058 CEP 2018-202 - Rev 02 2025/05/13 Valid Chemical 2025/05/13 Renewal|CEP granted|13/05/2025;
Minor revision|CEP granted|04/04/2024
. Collagen Peptide SICHUAN RAYBO BIOTECHNOLOGY CO. LTD. Guanghan CN 100054197;100095911 CEP 2019-322 - Rev 01 2025/05/13 Valid TSE 2025/05/13 Renewal|CEP granted|13/05/2025
2675 Irinotecan hydrochloride trihydrate COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2023-338 - Rev 00 2025/05/13 Valid 13/05/2030 Chemical 2025/05/13 New application|CEP granted|13/05/2025
2593 Docetaxel CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN 100041836;100068984 CEP 2022-295 - Rev 01 2025/05/13 Valid 28/09/2028 Chemical 2025/05/13 Minor revision|CEP granted|13/05/2025;
New application|CEP granted|28/09/2023
2422 Oseltamivir phosphate, Form-A HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2018-046 - Rev 02 2025/05/09 Valid Chemical 2026/02/27 Minor revision|Accepted - CEP remains valid|27/02/2026;
Renewal|CEP granted|09/05/2025;
Minor revision|CEP granted|25/09/2023;
Minor revision|Accepted - CEP remains valid|05/01/2022
2577 Oxcarbazepine SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2022-458 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
1681 Tramadol hydrochloride SUPRIYA LIFESCIENCE LIMITED Mumbai IN 100015796;100024574 CEP 2023-203 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
2857 Trazodone hydrochloride BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2023-228 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
1717 Desogestrel NEWCHEM S.p.A. Milano IT 100017847;100080332 CEP 2023-246 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
1200 Dobutamine hydrochloride D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN 100023552;100032697 CEP 2023-369 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
1240 Mefenamic acid, Solara SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2025-076 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/12/22 Minor revision|Rejected|22/12/2025;
New application|CEP granted|09/05/2025
2577 Oxcarbazepine, Code 1138 milled grade F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT 100011866;100022277 CEP 2025-115 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
2856 Pirfenidone SNJ LABS PRIVATE LIMITED Dist. Rajkot IN 100051266;100089774 CEP 2024-165 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
810 Betamethasone sodium phosphate HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2023-440 - Rev 00 2025/05/09 Valid 09/05/2030 Chemical 2025/05/09 New application|CEP granted|09/05/2025
1120 Lisinopril dihydrate RICHTER THEMIS MEDICARE (I) PVT. LTD. Vapi IN 100012132;100018972 CEP 2018-223 - Rev 01 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025

数据库说明:

当前数据更新日期:2026年04月02日。
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