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 |
---|---|---|---|---|---|---|---|---|---|---|---|
2600 | Olmesartan medoxomil | CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN | 100038839;100060978 | CEP 2018-083 - Rev 04 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Renewal|CEP granted|25/04/2025; Minor revision|CEP granted|03/08/2023; Notification|Accepted - CEP remains valid|06/01/2023; Minor revision|Accepted - CEP remains valid|21/12/2022; Minor revision|CEP granted|06/09/2022; Monograph revision|CEP granted|06/05/2022 |
||
2017 | Oxaliplatin, Process HER-2 | HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE | 100012310;100021629 | CEP 2006-137 - Rev 06 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; Notification|CEP granted|02/10/2023; Notification|CEP granted|18/07/2022; Notification|CEP granted|24/03/2021 |
||
1614 | Estradiol valerate | ASPEN OSS B.V. Oss NL | 100011619;100050602 | CEP 2009-171 - Rev 02 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025 | ||
. | Foetal Bovine Serum | GLOBAL LIFE SCIENCES SOLUTIONS NEW ZEALAND Tauranga NZ | 100052523;100092494 | CEP 2000-211 - Rev 05 | 2025/04/25 | Valid | TSE | 2025/04/25 | Notification|CEP granted|25/04/2025; Notification|CEP granted|25/02/2022; Notification|CEP granted|05/06/2020 |
||
1517 | Flumequine | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2001-318 - Rev 05 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Notification|Rejected|08/04/2025; Minor revision|CEP granted|16/07/2020 |
||
944 | Piroxicam | PFIZER INC. New York US | 100004191;100077681 | CEP 2001-427 - Rev 02 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025 | ||
3059 | Melatonin | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2023-075 - Rev 03 | 2025/04/25 | Valid | 22/05/2029 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|17/02/2025; Notification|CEP granted|16/09/2024; New application|CEP granted|22/05/2024 |
|
2781 | Tolterodine tartrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2020-032 - Rev 01 | 2025/04/25 | Valid | 17/03/2026 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|Accepted - CEP remains valid|24/08/2023; New application|CEP granted|17/03/2021 |
|
2254 | Moxifloxacin hydrochloride | ENALTEC LABS PRIVATE LIMITED Navi Mumbai IN | 100015510;100024234 | CEP 2022-487 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
2296 | Pantoprazole sodium sesquihydrate | SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN | 100017920;100052986 | CEP 2013-350 - Rev 01 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Major revision|CEP granted|25/04/2025; Renewal|CEP granted|15/09/2020 |
||
2173 | Gabapentin | ZHEJIANG BAMBOO PHARMACEUTICALS CO.,LTD. Shaoxing CN | 100047946;100079294 | CEP 2023-027 - Rev 02 | 2025/04/25 | Valid | 04/01/2029 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|11/03/2024; New application|CEP granted|04/01/2024 |
|
1513 | Etofenamate | DUKE CHEM, S.A.U. Olérdola ES | 100022432;100031112 | CEP 2014-154 - Rev 02 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|27/02/2024; Renewal|CEP granted|02/10/2020 |
||
883 | Calcitriol | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1998-055 - Rev 08 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Monograph revision|Accepted - CEP remains valid|26/11/2024; Minor revision|CEP granted|16/08/2024; Notification|Rejected|06/06/2024; Notification|Accepted - CEP remains valid|06/06/2023; Minor revision|Accepted - CEP remains valid|21/04/2022; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|09/06/2021 |
||
916 | Hydroxyzine hydrochloride | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2010-076 - Rev 04 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|11/09/2024; Notification|Accepted - CEP remains valid|23/06/2023; Minor revision|CEP granted|03/08/2021 |
||
1444 | Macrogols, Types 3350 and 4000 | THE DOW CHEMICAL COMPANY Midland US | 100011909;100090025 | CEP 2006-085 - Rev 05 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; Administrative procedure|CEP granted|18/09/2024; Minor revision|Accepted - CEP remains valid|06/06/2024; Administrative procedure|CEP granted|29/03/2021; Minor revision|CEP granted|03/02/2021 |
||
2888 | Rupatadine fumarate, Micronised and Non-micronised | CADILA PHARMACEUTICALS LIMITED Ankleshwar IN | 100003616;100000498 | CEP 2018-161 - Rev 03 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Renewal|CEP granted|25/04/2025; Minor revision|CEP granted|25/01/2024; Minor revision|Accepted - CEP remains valid|01/08/2022; Minor revision|CEP granted|18/12/2020 |
||
2751 | Valaciclovir hydrochloride hydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2018-102 - Rev 03 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Renewal|CEP granted|25/04/2025; Minor revision|Accepted - CEP remains valid|20/08/2024; Minor revision|CEP granted|20/02/2024; Minor revision|Accepted - CEP remains valid|27/01/2021; Minor revision|CEP granted|07/08/2020 |
||
2333 | Fluvastatin sodium, Amorphous | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2016-075 - Rev 01 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Renewal|CEP granted|14/10/2022; Minor revision|Rejected|25/01/2022; Major revision|Rejected|14/09/2021 |
||
1750 | Fluticasone propionate, Micronised | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED London GB | 100005535;100093170 | CEP 2018-229 - Rev 03 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; Renewal|CEP granted|16/12/2024; Monograph revision|Accepted - CEP remains valid|12/07/2021; Notification|CEP granted|07/12/2020 |
||
2445 | Adapalene, Micronised and non-micronised | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2022-259 - Rev 01 | 2025/04/25 | Valid | 28/07/2028 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; New application|CEP granted|28/07/2023 |