| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2992 | Lacosamide | EMNAR PHARMA PRIVATE LIMITED Hyderabad IN | 100033980;100065255 | CEP 2023-438 - Rev 00 | 2025/10/10 | Valid | 10/10/2030 | Chemical | 2025/10/10 | New application|CEP granted|10/10/2025 | |
| 2288 | Citalopram hydrobromide | VIRUPAKSHA ORGANICS LIMITED Hyderabad IN | 100021606;100076961 | CEP 2021-437 - Rev 01 | 2025/10/10 | Valid | 29/08/2028 | Chemical | 2025/10/10 | Minor revision|CEP granted|10/10/2025; New application|CEP granted|30/08/2023 |
|
| 1705 | Sertraline hydrochloride, Form II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2024-117 - Rev 03 | 2025/10/10 | Valid | 05/06/2029 | Chemical | 2025/10/10 | Notification|CEP granted|10/10/2025; Administrative procedure|CEP granted|01/08/2024; Notification|CEP granted|25/07/2024; New application|CEP granted|05/06/2024 |
|
| 22 | Diazepam | RUSAN PHARMA LTD Mumbai IN | 100017165;100036742 | CEP 2024-260 - Rev 00 | 2025/10/10 | Valid | 10/10/2030 | Chemical | 2025/10/10 | New application|CEP granted|10/10/2025 | |
| 496 | Glycerol, VYCERIN™ GL 88 99.5% and VYCERIN™ GL 99 99.7% glycerin | VANTAGE OLEOCHEMICALS, INC. Chicago US | 100052386;100092241 | CEP 2024-360 - Rev 00 | 2025/10/10 | Valid | 10/10/2030 | TSE | 2025/10/10 | New application|CEP granted|10/10/2025 | |
| 2594 | Duloxetine hydrochloride | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2024-316 - Rev 00 | 2025/10/10 | Valid | 10/10/2030 | Chemical | 2025/10/10 | New application|CEP granted|10/10/2025 | |
| 330 | Gelatin, Limed bone gelatin | NITTA GELATIN INC Naniwa-Ku JP | 100038832;100060961 | CEP 2024-475 - Rev 00 | 2025/10/10 | Valid | 10/10/2030 | TSE | 2025/10/10 | New application|CEP granted|10/10/2025 | |
| 727 | Lidocaine | SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN | 100048410;100080174 | CEP 2024-285 - Rev 00 | 2025/10/09 | Valid | 09/10/2030 | Chemical | 2025/10/09 | New application|CEP granted|09/10/2025 | |
| 2235 | Methylphenidate hydrochloride | ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100033956;100079880 | CEP 2025-151 - Rev 00 | 2025/10/09 | Valid | 09/10/2030 | Chemical | 2025/10/09 | New application|CEP granted|09/10/2025 | |
| 2594 | Duloxetine hydrochloride, Vizag facility | SHODHANA LABORATORIES PRIVATE LIMITED Visakhapatnam IN | 100021550;100092686 | CEP 2025-283 - Rev 00 | 2025/10/09 | Valid | 09/10/2030 | Chemical | 2025/10/09 | New application|CEP granted|09/10/2025 | |
| 3095 | Dabigatran etexilate mesilate, Form-I | BIOCON LIMITED Pashamylaram IN | 100011487;100021549 | CEP 2024-046 - Rev 00 | 2025/10/09 | Valid | 09/10/2030 | Chemical | 2025/10/09 | New application|CEP granted|09/10/2025 | |
| 653 | Baclofen | VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100040217;100065484 | CEP 2024-145 - Rev 00 | 2025/10/09 | Valid | 09/10/2030 | Chemical | 2025/10/09 | New application|CEP granted|09/10/2025 | |
| 771 | Leucine | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-189 - Rev 01 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Notification|CEP granted|08/10/2025; Minor revision|Accepted - CEP remains valid|18/11/2024; Minor revision|Accepted - CEP remains valid|18/06/2024; Minor revision|Accepted - CEP remains valid|22/11/2022 |
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| 369 | Azathioprine, Process 2 | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2014-030 - Rev 02 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Minor revision|CEP granted|08/10/2025; Minor revision|Accepted - CEP remains valid|29/01/2024; Notification|CEP granted|20/10/2022; Minor revision|Accepted - CEP remains valid|10/06/2022 |
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| 785 | Proline | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2010-263 - Rev 02 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Notification|CEP granted|08/10/2025; Notification|CEP granted|11/06/2024; Minor revision|Accepted - CEP remains valid|11/08/2023; Notification|Accepted - CEP remains valid|09/02/2022; Minor revision|Accepted - CEP remains valid|18/11/2021 |
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| 653 | Baclofen | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2006-229 - Rev 03 | 2025/10/08 | Valid | Chemical | 2025/10/08 | Notification|CEP granted|08/10/2025; Notification|CEP granted|26/07/2024 |
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| 2992 | Lacosamide | LEE PHARMA LIMITED Hyderabad IN | 100014849;100042625 | CEP 2019-223 - Rev 01 | 2025/10/08 | Valid | 21/10/2026 | Chemical | 2025/10/08 | Minor revision|CEP granted|08/10/2025 | |
| 926 | Levonorgestrel, Micronised, Process II | QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN | 100016470;100025257 | CEP 2022-225 - Rev 02 | 2025/10/08 | Valid | 20/12/2027 | Chemical | 2025/10/08 | Administrative procedure|CEP granted|08/10/2025; Notification|CEP granted|23/09/2025; New application|CEP granted|20/12/2022 |
|
| 711 | Cyclophosphamide monohydrate | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2020-083 - Rev 03 | 2025/10/08 | Valid | 27/08/2026 | Chemical | 2025/10/08 | Minor revision|CEP granted|08/10/2025; Monograph revision|CEP granted|09/01/2023; Notification|CEP granted|21/07/2022; New application|CEP granted|27/08/2021 |
|
| 20 | Dextromethorphan hydrobromide monohydrate | WANBURY LIMITED Vashi, Navi Mumbai IN | 100021364;100030068 | CEP 2022-268 - Rev 01 | 2025/10/08 | Valid | 03/09/2029 | Chemical | 2025/10/08 | Monograph revision|CEP granted|08/10/2025; New application|CEP granted|03/09/2024 |
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