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
1280 Zolpidem tartrate, Site-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2020-320 - Rev 03 2025/10/14 Valid Chemical 2025/10/14 Renewal|CEP granted|14/10/2025;
Notification|CEP granted|24/01/2024;
Minor revision|CEP granted|22/09/2022;
New application|CEP granted|13/01/2021
331 Gentamicin sulfate FUAN PHARMACEUTICAL GROUP YANTAI JUSTAWARE PHARMACEUTICAL CO., LTD. Yantai CN 100038871;100061089 CEP 2024-008 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
2296 Pantoprazole sodium sesquihydrate, Process III IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN 100017919;100037377 CEP 2025-303 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
2015 Ebastine, Process-II MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2024-268 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
2675 Irinotecan hydrochloride trihydrate, Process-2 LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2025-394 - Rev 00 2025/10/14 Valid 14/10/2030 Chemical 2025/10/14 New application|CEP granted|14/10/2025
576 Allopurinol MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2000-015 - Rev 08 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|25/07/2024
2572 Risedronate sodium 2.5-hydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-009 - Rev 02 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|30/07/2024;
Monograph revision|Accepted - CEP remains valid|10/07/2023
1451 Mupirocin calcium CONCORD BIOTECH LIMITED Ahmedabad IN 100005519;100000897 CEP 2015-119 - Rev 01 2025/10/10 Valid Chemical 2025/10/10 Minor revision|CEP granted|10/10/2025;
Minor revision|Accepted - CEP remains valid|24/10/2023;
Renewal|CEP granted|16/04/2021
2173 Gabapentin MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-185 - Rev 03 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|26/07/2024
2136 Ritonavir, Form-I MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-346 - Rev 02 2025/10/10 Valid Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|26/07/2024;
Minor revision|Accepted - CEP remains valid|24/03/2021
2898 Atazanavir sulfate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-203 - Rev 04 2025/10/10 Valid 08/11/2026 Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|24/07/2024;
Minor revision|CEP granted|17/10/2022;
Major revision|CEP granted|16/09/2022
1611 Diosmin BIORESINE INTERNATIONALE Kenitra MA 100015357;100092292 CEP 2019-205 - Rev 02 2025/10/10 Valid Chemical 2025/10/10 Renewal|CEP granted|10/10/2025;
Minor revision|CEP granted|07/09/2022
1846 Rosemary oil, Rectified; Tunisian type FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2019-276 - Rev 01 2025/10/10 Valid Herbal 2025/10/10 Renewal|CEP granted|10/10/2025;
Notification|Accepted - CEP remains valid|13/08/2021
2931 Sorafenib tosilate GRANULES INDIA LIMITED Hyderabad IN 100011671;100097387 CEP 2022-386 - Rev 01 2025/10/10 Valid 15/11/2029 Chemical 2025/10/10 Monograph revision|CEP granted|10/10/2025;
New application|CEP granted|15/11/2024
766 Flucytosine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2020-423 - Rev 02 2025/10/10 Valid 03/03/2027 Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Notification|CEP granted|26/07/2024;
Minor revision|Accepted - CEP remains valid|20/09/2022;
New application|CEP granted|03/03/2022
2992 Lacosamide EMNAR PHARMA PRIVATE LIMITED Hyderabad IN 100033980;100065255 CEP 2023-438 - Rev 00 2025/10/10 Valid 10/10/2030 Chemical 2025/10/10 New application|CEP granted|10/10/2025
2288 Citalopram hydrobromide VIRUPAKSHA ORGANICS LIMITED Hyderabad IN 100021606;100076961 CEP 2021-437 - Rev 01 2025/10/10 Valid 29/08/2028 Chemical 2025/10/10 Minor revision|CEP granted|10/10/2025;
New application|CEP granted|30/08/2023
1705 Sertraline hydrochloride, Form II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2024-117 - Rev 03 2025/10/10 Valid 05/06/2029 Chemical 2025/10/10 Notification|CEP granted|10/10/2025;
Administrative procedure|CEP granted|01/08/2024;
Notification|CEP granted|25/07/2024;
New application|CEP granted|05/06/2024
22 Diazepam RUSAN PHARMA LTD Mumbai IN 100017165;100036742 CEP 2024-260 - Rev 00 2025/10/10 Valid 10/10/2030 Chemical 2025/10/10 New application|CEP granted|10/10/2025
2594 Duloxetine hydrochloride IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2024-316 - Rev 00 2025/10/10 Valid 10/10/2030 Chemical 2025/10/10 New application|CEP granted|10/10/2025

数据库说明:

当前数据更新日期:2026年02月10日。
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