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 |
---|---|---|---|---|---|---|---|---|---|---|---|
1649 | Azithromycin, Dihydrate | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shangyu CN | R1-CEP 2013-153 - Rev 03 | 2023/08/10 | Valid | Chemical | 2024/06/05 | Notification|Accepted - CEP remains valid|05/06/2024; Major revision|CEP granted|10/08/2023; Minor revision|CEP granted|24/05/2022; Minor revision|CEP granted|04/11/2021 |
|||
2114 | Lysine acetate, NC | Ajinomoto Co., Inc. Tokyo JP | R1-CEP 2014-063 - Rev 02 | 2023/08/10 | Valid | Chemical | 2023/08/10 | Monograph revision|CEP granted|10/08/2023; Notification|CEP granted|27/09/2021; Renewal|CEP granted|14/10/2020 |
|||
2593 | Docetaxel | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | R1-CEP 2015-336 - Rev 01 | 2023/08/10 | Valid | Chemical | 2023/08/10 | Notification|CEP granted|10/08/2023; Renewal|CEP granted|12/01/2022; Minor revision|CEP granted|25/11/2020 |
|||
96 | Mercaptopurine monohydrate | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | R0-CEP 2021-275 - Rev 00 | 2023/08/09 | Valid | 09/08/2028 | Chemical | 2023/08/09 | New application|CEP granted|09/08/2023 | ||
11 | Benzocaine | APEX HEALTHCARE LIMITED Ankleshwar IN | R0-CEP 2022-102 - Rev 00 | 2023/08/09 | Valid | 09/08/2028 | Chemical | 2023/08/09 | New application|CEP granted|09/08/2023 | ||
2604 | Ropinirole hydrochloride | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | R0-CEP 2022-227 - Rev 00 | 2023/08/09 | Valid | 09/08/2028 | Chemical | 2023/08/09 | New application|CEP granted|09/08/2023 | ||
1654 | Lymecycline, Type 2 | OLON S.P.A. Rodano IT | R0-CEP 2023-172 - Rev 00 | 2023/08/09 | Valid | 09/08/2028 | Chemical | 2023/08/09 | New application|CEP granted|09/08/2023 | ||
1013 | Felodipine | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | R1-CEP 2013-307 - Rev 02 | 2023/08/09 | Valid | Chemical | 2023/08/09 | Minor revision|CEP granted|09/08/2023; Monograph revision|CEP granted|22/03/2023 |
|||
2888 | Rupatadine fumarate | URQUIMA S.A. Palau-solità i Plegamans ES | R1-CEP 2017-202 - Rev 00 | 2023/08/09 | Valid | Chemical | 2023/08/09 | Renewal|CEP granted|09/08/2023; Minor revision|CEP granted|14/12/2022; Notification|Rejected|07/10/2022 |
|||
3087 | Ticagrelor | Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN | R0-CEP 2021-303 - Rev 00 | 2023/08/08 | Valid | 08/08/2028 | Chemical | 2023/08/08 | New application|CEP granted|08/08/2023 | ||
2154 | Telmisartan | HETERO LABS LIMITED Hyderabad IN | R0-CEP 2022-041 - Rev 00 | 2023/08/08 | Valid | 08/08/2028 | Chemical | 2023/08/08 | New application|CEP granted|08/08/2023 | ||
285 | Noradrenaline tartrate | HARMAN FINOCHEM LIMITED Mumbai IN | R0-CEP 2022-253 - Rev 00 | 2023/08/08 | Valid | 08/08/2028 | Chemical | 2024/06/14 | Minor revision|Accepted - CEP remains valid|14/06/2024; New application|CEP granted|08/08/2023 |
||
2054 | Clofazimine | ARENE LIFE SCIENCES PRIVATE LIMITED Sangareddy IN | R0-CEP 2023-008 - Rev 00 | 2023/08/08 | Valid | 08/08/2028 | Chemical | 2023/08/08 | New application|CEP granted|08/08/2023 | ||
729 | Naloxone hydrochloride dihydrate, Code 1492 | SPECGX LLC Webster Groves US | R1-CEP 2009-294 - Rev 01 | 2023/08/08 | Valid | Chemical | 2023/08/08 | Minor revision|CEP granted|08/08/2023; Notification|Accepted - CEP remains valid|06/08/2021 |
|||
. | Bovine pericardium | BRAILE BIOMEDICA INDUSTRIA, COMERCIO E REPRESENTACOES LTDA. São José do Rio Preto BR | R1-CEP 2018-114 - Rev 00 | 2023/08/08 | Valid | TSE | 2023/08/08 | Renewal|CEP granted|08/08/2023 | |||
2733 | Escitalopram oxalate, Process-III | NEULAND LABORATORIES LIMITED Hyderabad IN | R0-CEP 2021-161 - Rev 01 | 2023/08/07 | Valid | 27/07/2026 | Chemical | 2024/03/06 | Minor revision|Accepted - CEP remains valid|06/03/2024; Minor revision|CEP granted|07/08/2023; Minor revision|Accepted - CEP remains valid|02/02/2022; New application|CEP granted|27/07/2021 |
||
2244 | Tacrolimus monohydrate | LEK PHARMACEUTICALS D.D. Ljubljana SI | R0-CEP 2021-204 - Rev 01 | 2023/08/07 | Valid | 02/12/2027 | Chemical | 2023/08/07 | Notification|CEP granted|07/08/2023; New application|CEP granted|02/12/2022 |
||
1187 | Carmustine | NERPHARMA S.R.L. Nerviano IT | R0-CEP 2021-212 - Rev 00 | 2023/08/07 | Valid | 07/08/2028 | Chemical | 2023/08/07 | New application|CEP granted|07/08/2023 | ||
2932 | Rivaroxaban | MEGAFINE PHARMA (P) LIMITED Mumbai IN | R0-CEP 2021-277 - Rev 01 | 2023/08/07 | Valid | 13/05/2027 | Chemical | 2023/08/07 | Minor revision|CEP granted|07/08/2023; New application|CEP granted|16/05/2022 |
||
1558 | Propofol | GUANGDONG JIABO PHARMACEUTICAL CO., LTD. Qingyuan CN | R0-CEP 2022-494 - Rev 00 | 2023/08/07 | Valid | 07/08/2028 | Chemical | 2024/05/17 | Notification|Accepted - CEP remains valid|17/05/2024; New application|CEP granted|07/08/2023 |