| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1199 | Dipyridamole | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-244 - Rev 05 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|30/07/2024; Major revision|CEP granted|31/03/2022 |
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| 408 | Methadone hydrochloride | PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVATE LIMITED Mumbai IN | 100014944;100038683 | CEP 2003-062 - Rev 02 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Minor revision|CEP granted|30/09/2025; Notification|CEP granted|03/10/2023 |
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| 1059 | Zidovudine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2007-318 - Rev 07 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|03/05/2023; Monograph revision|Accepted - CEP remains valid|07/01/2022; Minor revision|CEP granted|27/05/2020 |
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| 1049 | Threonine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-044 - Rev 01 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|Accepted - CEP remains valid|07/05/2024; Minor revision|Accepted - CEP remains valid|08/08/2023; Minor revision|Accepted - CEP remains valid|20/03/2023 |
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| 1705 | Sertraline hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-304 - Rev 05 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|24/04/2023; Major revision|Rejected|23/03/2023 |
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| 2136 | Ritonavir, Form-II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-221 - Rev 03 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|25/07/2024; Minor revision|Accepted - CEP remains valid|20/09/2023; Minor revision|CEP granted|06/09/2021 |
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| 2372 | Esomeprazole magnesium trihydrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2015-023 - Rev 02 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|29/07/2024; Renewal|CEP granted|26/11/2021; Minor revision|CEP granted|09/12/2020 |
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| 330 | Gelatin, Limed bone gelatin | NITTA GELATIN INDIA LIMITED Ernakulam IN | 100032296;100097649 | CEP 2020-193 - Rev 01 | 2025/09/30 | Valid | TSE | 2025/09/30 | Renewal|CEP granted|30/09/2025; New application|CEP granted|05/01/2021 |
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| 1665 | Betahistine dihydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2022-505 - Rev 02 | 2025/09/30 | Valid | 25/08/2028 | Chemical | 2025/09/30 | Notification|CEP granted|30/09/2025; Notification|CEP granted|18/07/2024; New application|CEP granted|25/08/2023 |
|
| 2815 | Entecavir monohydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2017-043 - Rev 02 | 2025/09/30 | Valid | Chemical | 2025/09/30 | Minor revision|CEP granted|30/09/2025; Notification|CEP granted|06/12/2023; Renewal|CEP granted|03/01/2023 |
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| 2541 | Quetiapine Fumarate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2014-224 - Rev 04 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Notification|CEP granted|29/09/2025; Notification|CEP granted|25/07/2024; Minor revision|Accepted - CEP remains valid|30/04/2024; Minor revision|CEP granted|02/12/2022; Notification|CEP granted|31/08/2021; Renewal|CEP granted|16/03/2021 |
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| 2124 | Loratadine, Form I | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2007-254 - Rev 04 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Minor revision|CEP granted|29/09/2025; Notification|CEP granted|07/07/2022; Minor revision|CEP granted|22/04/2020 |
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| 2422 | Oseltamivir phosphate | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2015-348 - Rev 03 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Minor revision|CEP granted|29/09/2025; Renewal|CEP granted|28/03/2024; Major revision|CEP granted|03/12/2021 |
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| 1794 | Paclitaxel, Semi-synthetic process | FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN | 100011513;100018607 | CEP 2008-181 - Rev 12 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Minor revision|CEP granted|29/09/2025; Major revision|CEP granted|21/03/2025; Major revision|Accepted - CEP remains valid|31/10/2023; Major revision|CEP granted|17/10/2022; Notification|Accepted - CEP remains valid|17/06/2022; Administrative procedure|CEP granted|09/05/2022; Major revision|CEP granted|29/04/2022; Minor revision|Accepted - CEP remains valid|27/11/2020; Administrative procedure|CEP granted|29/04/2020; Minor revision|CEP granted|31/03/2020 |
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| 2591 | Celecoxib | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2012-183 - Rev 06 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Notification|CEP granted|29/09/2025; Minor revision|CEP granted|27/03/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|15/02/2023; Minor revision|CEP granted|26/09/2022 |
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| 2606 | Tadalafil, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-201 - Rev 04 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Notification|CEP granted|29/09/2025; Renewal|CEP granted|02/01/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|27/02/2023 |
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| 2733 | Escitalopram oxalate, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-130 - Rev 04 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Notification|CEP granted|29/09/2025; Renewal|CEP granted|21/03/2025; Notification|CEP granted|29/07/2024; Minor revision|CEP granted|13/07/2023 |
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| 2778 | Sitagliptin phosphate monohydrate, Crystalline, micronised and non-micronised | MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN | 100014794;100023345 | CEP 2016-262 - Rev 02 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Major revision|CEP granted|29/09/2025; Renewal|CEP granted|12/01/2024; Minor revision|Accepted - CEP remains valid|01/03/2022; Notification|Accepted - CEP remains valid|15/12/2020 |
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| 2203 | Citalopram hydrochloride, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-233 - Rev 03 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Notification|CEP granted|29/09/2025; Renewal|CEP granted|07/05/2025; Notification|CEP granted|29/07/2024 |
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| 2338 | Mirtazapine, Process-II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-127 - Rev 04 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Notification|CEP granted|29/09/2025; Renewal|CEP granted|06/02/2025; Notification|CEP granted|18/07/2024; Minor revision|CEP granted|28/10/2022 |
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