| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 141 | Ethionamide | APICHEM LABORATORIES PRIVATE LIMITED Yadadri Bhuvanagiri District IN | 100049373;100087707 | CEP 2024-502 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2577 | Oxcarbazepine | ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100033956;100079880 | CEP 2024-343 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2288 | Citalopram hydrobromide, Sulfuric Acid Process, Micronised and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2025-004 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| . | Glutaraldehyde fixed bovine pericardium | MERIL LIFE SCIENCES PRIVATE LIMITED Vapi IN | 100054083;100095677 | CEP 2024-425 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | TSE | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2775 | Nebivolol hydrochloride, Micronised | F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT | 100011866;100022277 | CEP 2024-214 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2244 | Tacrolimus monohydrate | CONCORD BIOTECH LIMITED Ahmedabad IN | 100005519;100000897 | CEP 2018-216 - Rev 01 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Renewal|CEP granted|25/04/2025 | ||
| 1183 | Calcium dobesilate monohydrate | BAJAJ HEALTHCARE LIMITED Thane IN | 100021782;100061986 | CEP 2023-106 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2933 | Deferasirox | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | CEP 2021-176 - Rev 01 | 2025/04/25 | Valid | 23/10/2028 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; New application|CEP granted|23/10/2023 |
|
| 2778 | Sitagliptin phosphate monohydrate, (1466) | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2023-205 - Rev 01 | 2025/04/25 | Valid | 12/02/2029 | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; New application|CEP granted|12/02/2024 |
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| 2191 | Atorvastatin calcium, 317500 | KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI | 100000627;100009540 | CEP 2023-270 - Rev 03 | 2025/04/25 | Valid | 24/01/2029 | Chemical | 2025/04/25 | Administrative procedure|CEP granted|25/04/2025; Minor revision|CEP granted|08/04/2025; Administrative procedure|CEP granted|06/02/2024; New application|CEP granted|24/01/2024 |
|
| 1088 | Cinchocaine Hydrochloride, Micronised and non-micronised | PHARMASYNTHESE Saint Pierre Les Elbeuf FR | 100012546;100020952 | CEP 2007-117 - Rev 03 | 2025/04/16 | Valid | Chemical | 2025/08/01 | Minor revision|Accepted - CEP remains valid|01/08/2025; Notification|CEP granted|16/04/2025; Minor revision|CEP granted|23/02/2023 |
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| 309 | Acetylsalicylic acid | The Andhra Sugars Limited Tanuku IN | 100021433;100030128 | CEP 2000-042 - Rev 05 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Minor revision|CEP granted|16/04/2025; Minor revision|CEP granted|20/04/2021 |
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| 1734 | Terbinafine hydrochloride | SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN | 100014777;100050265 | CEP 2007-279 - Rev 06 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Minor revision|CEP granted|16/04/2025; Notification|CEP granted|17/02/2020 |
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| 1378 | Valproic acid | SCI PHARMTECH, INC. Taoyuan City TW | 100017752;100052419 | CEP 2003-108 - Rev 06 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Minor revision|CEP granted|16/04/2025; Minor revision|Accepted - CEP remains valid|28/10/2022 |
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| 1322 | Fenofibrate, Non-micronised, micronised | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2008-023 - Rev 05 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Notification|CEP granted|16/04/2025; Minor revision|CEP granted|09/02/2024; Minor revision|Accepted - CEP remains valid|27/05/2021 |
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| 408 | Methadone hydrochloride | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2011-086 - Rev 01 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Notification|CEP granted|16/04/2025; Minor revision|Accepted - CEP remains valid|06/02/2023 |
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| 727 | Lidocaine | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2014-234 - Rev 02 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Notification|CEP granted|16/04/2025; Minor revision|CEP granted|03/04/2024; Minor revision|Accepted - CEP remains valid|24/03/2023; Renewal|CEP granted|08/07/2021 |
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| 1002 | Diclofenac sodium | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2009-303 - Rev 05 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Minor revision|CEP granted|16/04/2025; Minor revision|Accepted - CEP remains valid|30/06/2023; Minor revision|CEP granted|01/06/2021; Minor revision|CEP granted|28/01/2021 |
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| 1378 | Valproic acid | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2015-158 - Rev 02 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Notification|CEP granted|16/04/2025; Minor revision|CEP granted|05/04/2024; Renewal|CEP granted|31/05/2022 |
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| 227 | Lidocaine hydrochloride monohydrate | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2015-044 - Rev 01 | 2025/04/16 | Valid | Chemical | 2025/04/16 | Notification|CEP granted|16/04/2025; Renewal|CEP granted|12/07/2021; Minor revision|CEP granted|14/04/2021 |
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