| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2531 | Clopidogrel hydrogen sulfate, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-142 - Rev 02 | 2025/09/16 | Valid | 15/09/2026 | Chemical | 2025/09/16 | Notification|CEP granted|16/09/2025; Notification|CEP granted|22/07/2024 |
|
| 2296 | Pantoprazole sodium sesquihydrate | Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi Istanbul TR | 100022492;100082995 | CEP 2024-048 - Rev 00 | 2025/09/15 | Valid | 15/09/2030 | Chemical | 2025/09/15 | New application|CEP granted|15/09/2025 | |
| 1425 | Fosfomycin trometamol | CLAROCHEM IRELAND LTD. Dublin 15 IE | 100016003;100024745 | CEP 2022-327 - Rev 01 | 2025/09/15 | Valid | 17/05/2028 | Chemical | 2025/09/15 | Minor revision|CEP granted|15/09/2025; New application|CEP granted|17/05/2023 |
|
| 811 | Betamethasone valerate | AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN | 100011968;100018590 | CEP 2021-120 - Rev 02 | 2025/09/15 | Valid | 31/05/2027 | Chemical | 2025/09/15 | Minor revision|CEP granted|15/09/2025; Minor revision|CEP granted|14/09/2022; New application|CEP granted|31/05/2022 |
|
| 2531 | Clopidogrel hydrogen sulfate, Form II, AS | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2025-295 - Rev 01 | 2025/09/15 | Valid | 28/08/2030 | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; New application|CEP granted|28/08/2025 |
|
| 1029 | Mexiletine hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2021-421 - Rev 01 | 2025/09/15 | Valid | 10/03/2028 | Chemical | 2025/09/15 | Minor revision|CEP granted|15/09/2025; Minor revision|Accepted - CEP remains valid|05/09/2024; New application|CEP granted|10/03/2023 |
|
| 1711 | Buspirone hydrochloride | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2024-108 - Rev 00 | 2025/09/15 | Valid | 15/09/2030 | Chemical | 2025/09/15 | New application|CEP granted|15/09/2025 | |
| 1649 | Azithromycin, Dihydrate | SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN | 100012114;100052387 | CEP 2025-033 - Rev 00 | 2025/09/15 | Valid | 15/09/2030 | Chemical | 2025/09/15 | New application|CEP granted|15/09/2025 | |
| 2255 | Nevirapine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-075 - Rev 06 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|19/12/2023; Notification|CEP granted|31/08/2021 |
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| 2615 | Lopinavir | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-011 - Rev 04 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Notification|CEP granted|23/07/2024; Major revision|CEP granted|31/01/2024; Minor revision|CEP granted|30/08/2021 |
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| 2254 | Moxifloxacin hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-201 - Rev 04 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Minor revision|CEP granted|19/07/2024; Minor revision|CEP granted|25/10/2023; Notification|CEP granted|31/08/2021; Renewal|CEP granted|02/09/2020 |
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| 2124 | Loratadine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2007-171 - Rev 06 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Notification|CEP granted|11/07/2024; Minor revision|CEP granted|07/03/2024; Minor revision|CEP granted|24/01/2023 |
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| 2640 | Atomoxetine hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-271 - Rev 04 | 2025/09/15 | Valid | Chemical | 2025/09/15 | Notification|CEP granted|15/09/2025; Minor revision|CEP granted|05/02/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|31/08/2021 |
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| 737 | Hyoscine butylbromide | ALKALOIDS PRIVATE LIMITED Secunderabad IN | 100021602;100041426 | CEP 2002-158 - Rev 06 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; Transfer of holdership|CEP granted|11/12/2023; Notification|CEP granted|19/02/2021 |
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| 1702 | Naproxen sodium | ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN | 100011826;100018693 | CEP 2010-021 - Rev 03 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Administrative procedure|CEP granted|12/09/2025; Minor revision|CEP granted|04/09/2025; Notification|Accepted - CEP remains valid|10/11/2023; Notification|Accepted - CEP remains valid|05/01/2022 |
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| 1691 | Dacarbazine | VUAB PHARMA A.S. Roztoky CZ | 100000440;100007827 | CEP 2012-330 - Rev 03 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Notification|CEP granted|12/09/2025; Notification|Accepted - CEP remains valid|05/07/2023; Notification|CEP granted|26/05/2023; Monograph revision|Accepted - CEP remains valid|21/07/2021; Minor revision|CEP granted|26/02/2021; Notification|Rejected|18/12/2020 |
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| 2585 | Rizatriptan benzoate | APOTEX PHARMACHEM INDIA PRIVATE LIMITED Bangalore IN | 100012611;100041734 | CEP 2013-206 - Rev 01 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; Renewal|CEP granted|30/11/2020 |
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| 333 | Heparin sodium | HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD. Shijiazhuang CN | 100016151;100061309 | CEP 2005-270 - Rev 13 | 2025/09/12 | Valid | Chemical | 2026/01/21 | Monograph revision|Accepted - CEP remains valid|21/01/2026; Major revision|CEP granted|12/09/2025; Monograph revision|Accepted - CEP remains valid|18/06/2024; Minor revision|CEP granted|01/03/2024; Minor revision|CEP granted|21/09/2022; Major revision|CEP granted|02/11/2021; Minor revision|CEP granted|06/10/2020; Notification|CEP granted|24/03/2020 |
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| 1733 | Piracetam | NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN | 100021339;100054155 | CEP 2004-083 - Rev 08 | 2025/09/12 | Valid | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; Minor revision|Accepted - CEP remains valid|03/08/2023; Minor revision|Accepted - CEP remains valid|14/09/2021; Administrative procedure|CEP granted|21/04/2021; Monograph revision|Accepted - CEP remains valid|30/03/2021; Minor revision|CEP granted|25/11/2020; Minor revision|Accepted - CEP remains valid|23/06/2020 |
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| 1362 | Prilocaine | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2020-347 - Rev 02 | 2025/09/12 | Valid | 09/12/2027 | Chemical | 2025/09/12 | Minor revision|CEP granted|12/09/2025; Notification|CEP granted|16/09/2024; New application|CEP granted|09/12/2022 |
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