| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2217 | Lamivudine, Form II | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2007-103 - Rev 04 | 2025/09/26 | Valid | Chemical | 2025/09/26 | Minor revision|CEP granted|26/09/2025 | ||
| 2780 | Temozolomide | EXCELLA GMBH & CO. KG Feucht DE | 100012030;100020739 | CEP 2018-246 - Rev 04 | 2025/09/26 | Valid | Chemical | 2025/09/26 | Renewal|CEP granted|26/09/2025; Minor revision|CEP granted|12/04/2024; Administrative procedure|CEP granted|12/12/2023; Minor revision|CEP granted|20/07/2021; Notification|Accepted - CEP remains valid|01/10/2020 |
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| 2993 | Nilotinib hydrochloride monohydrate, Crystalline form-B, micronised and non-micronised | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2020-176 - Rev 01 | 2025/09/26 | Valid | 06/12/2027 | Chemical | 2025/09/26 | Minor revision|CEP granted|26/09/2025; New application|CEP granted|06/12/2022 |
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| 2132 | Torasemide | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2010-278 - Rev 02 | 2025/09/26 | Valid | Chemical | 2025/09/26 | Major revision|CEP granted|26/09/2025; Minor revision|CEP granted|11/07/2023 |
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| 2577 | Oxcarbazepine | BAJAJ HEALTHCARE LIMITED Thane IN | 100021782;100061986 | CEP 2021-340 - Rev 01 | 2025/09/26 | Valid | 17/02/2030 | Chemical | 2025/09/26 | Minor revision|CEP granted|26/09/2025; New application|CEP granted|17/02/2025 |
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| 1300 | Cefuroxime axetil | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2002-252 - Rev 08 | 2025/09/26 | Valid | Chemical | 2025/09/26 | Minor revision|CEP granted|26/09/2025; Notification|CEP granted|13/12/2023; Notification|Accepted - CEP remains valid|06/12/2022; Notification|Rejected|03/11/2022; Minor revision|Accepted - CEP remains valid|06/08/2021; Minor revision|CEP granted|05/03/2021; Minor revision|CEP granted|11/01/2021 |
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| 2154 | Telmisartan, Site II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2020-290 - Rev 03 | 2025/09/26 | Valid | Chemical | 2025/09/26 | Renewal|CEP granted|26/09/2025; Minor revision|CEP granted|30/10/2024; Notification|CEP granted|05/01/2024; New application|CEP granted|15/12/2020 |
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| 2338 | Mirtazapine, Hemihydrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2009-399 - Rev 06 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|30/07/2024; Administrative procedure|CEP granted|18/11/2022; Minor revision|CEP granted|28/10/2022 |
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| 2416 | Pramipexole dihydrochloride monohydrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-038 - Rev 06 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|30/07/2024; Notification|CEP granted|28/09/2021 |
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| 2002 | Proguanil hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2009-199 - Rev 05 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|30/07/2024; Notification|CEP granted|28/09/2021; Minor revision|CEP granted|28/09/2020 |
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| 2573 | Candesartan cilexetil | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2011-259 - Rev 07 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|29/07/2024; Notification|CEP granted|22/06/2022 |
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| 2203 | Citalopram hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2010-007 - Rev 05 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|29/07/2024 |
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| 2733 | Escitalopram oxalate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2016-164 - Rev 02 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|29/07/2024; Renewal|CEP granted|08/03/2022; Minor revision|Accepted - CEP remains valid|29/05/2020 |
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| 2778 | Sitagliptin phosphate monohydrate, Product code: SPT-4 | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2025-020 - Rev 00 | 2025/09/25 | Valid | 25/09/2030 | Chemical | 2025/09/25 | New application|CEP granted|25/09/2025 | |
| 2630 | Rivastigmine hydrogen tartrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-003 - Rev 04 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|30/07/2024; Notification|CEP granted|28/09/2021; Minor revision|CEP granted|24/06/2021 |
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| 330 | Gelatin, Caustic and lime hide gelatin | GELITA AG Eberbach DE | 100012955;100080863 | CEP 2021-504 - Rev 01 | 2025/09/25 | Valid | 02/06/2027 | TSE | 2025/09/25 | Transfer of holdership|CEP granted|25/09/2025; New application|CEP granted|02/06/2022 |
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| 2606 | Tadalafil | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2012-021 - Rev 04 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|31/07/2024 |
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| 930 | Lysine Hydrochloride | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2012-007 - Rev 01 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025; Notification|Accepted - CEP remains valid|07/05/2024; Minor revision|Accepted - CEP remains valid|11/08/2023; Notification|Accepted - CEP remains valid|11/02/2022; Minor revision|Accepted - CEP remains valid|16/12/2021 |
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| 312 | Betamethasone, Micronised | MSD EUROPE BELGIUM Watermael-Boitsfort BE | 100049238;100083482 | CEP 2012-214 - Rev 01 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025 | ||
| 1765 | Salmeterol xinafoate | MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN | 100014822;100073679 | CEP 2010-097 - Rev 02 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025; Minor revision|Accepted - CEP remains valid|27/11/2020; Notification|Rejected|06/10/2020 |
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