| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 626 | Neostigmine metilsulfate | MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN | 100023737;100061579 | CEP 2019-024 - Rev 02 | 2025/09/29 | Valid | Chemical | 2025/09/29 | Renewal|CEP granted|29/09/2025; Administrative procedure|CEP granted|30/04/2024 |
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| 572 | Timolol maleate | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2022-322 - Rev 01 | 2025/09/29 | Valid | 28/06/2028 | Chemical | 2025/09/29 | Minor revision|CEP granted|29/09/2025; New application|CEP granted|28/06/2023 |
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| 875 | Tranexamic acid | AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN | 100021822;100030527 | CEP 2019-250 - Rev 04 | 2025/09/29 | Valid | 28/07/2026 | Chemical | 2025/09/29 | Major revision|CEP granted|29/09/2025; Minor revision|CEP granted|02/01/2025; Administrative procedure|CEP granted|04/04/2022; Notification|CEP granted|18/01/2022 |
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| 285 | Noradrenaline tartrate | HAMELN RDS S.R.O. Modra SK | 100000646;100003437 | CEP 2023-090 - Rev 02 | 2025/09/29 | Valid | 25/07/2029 | Chemical | 2025/09/29 | Minor revision|CEP granted|29/09/2025; Administrative procedure|CEP granted|01/08/2024; New application|CEP granted|26/07/2024 |
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| 2887 | Raltegravir potassium | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2020-216 - Rev 02 | 2025/09/29 | Valid | 25/07/2027 | Chemical | 2025/09/29 | Notification|CEP granted|29/09/2025; Notification|CEP granted|25/07/2024; Monograph revision|Accepted - CEP remains valid|30/03/2023; New application|CEP granted|25/07/2022 |
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| 2779 | Solifenacin succinate, Process-II | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2021-510 - Rev 02 | 2025/09/26 | Valid | 20/06/2027 | Chemical | 2025/09/26 | Minor revision|CEP granted|26/09/2025; Major revision|CEP granted|19/12/2024; Minor revision|Accepted - CEP remains valid|05/07/2024; New application|CEP granted|20/06/2022 |
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| 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 |
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