| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3078 | Riociguat, Modification I, micronised | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2023-191 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 | |
| 2631 | Rosuvastatin calcium, ZH code | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-407 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 | |
| 1750 | Fluticasone propionate | CURIA SPAIN S.A.U. Boecillo ES | 100011649;100019586 | CEP 2013-315 - Rev 02 | 2025/02/11 | Valid | Chemical | 2025/02/11 | Minor revision|CEP granted|11/02/2025; Notification|CEP granted|25/08/2021; Monograph revision|Accepted - CEP remains valid|20/04/2021 |
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| 931 | Metformin Hydrochloride | ABHILASHA PHARMA PRIVATE LIMITED Ankleshwar IN | 100050097;100087479 | CEP 2024-016 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 | |
| 2637 | Pemetrexed disodium heptahydrate | SHIVALIK RASAYAN LIMITED Bharuch IN | 100048259;100079859 | CEP 2023-301 - Rev 00 | 2025/02/11 | Valid | 11/02/2030 | Chemical | 2025/02/11 | New application|CEP granted|11/02/2025 | |
| 1181 | Buprenorphine hydrochloride | TAPI CZECH INDUSTRIES S.R.O. Opava CZ | 100051642;100090678 | CEP 2004-251 - Rev 06 | 2025/02/10 | Valid | Chemical | 2025/02/10 | Notification|CEP granted|10/02/2025; Minor revision|CEP granted|14/05/2024; Notification|CEP granted|21/01/2022; Minor revision|Accepted - CEP remains valid|26/07/2021 |
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| 139 | Estradiol benzoate | VALDEPHARM Val de Reuil FR | 100011898;100018788 | CEP 2012-144 - Rev 02 | 2025/02/10 | Valid | Chemical | 2025/02/10 | Minor revision|CEP granted|10/02/2025; Minor revision|CEP granted|11/07/2023; Minor revision|Accepted - CEP remains valid|26/09/2022 |
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| 2644 | Remifentanil hydrochloride | CILAG AG Schaffhausen CH | 100000298;100001981 | CEP 2018-296 - Rev 02 | 2025/02/10 | Valid | Chemical | 2025/02/10 | Renewal|CEP granted|10/02/2025; Minor revision|CEP granted|22/03/2022 |
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| 2757 | Aprepitant | VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN | 100049012;100082223 | CEP 2019-025 - Rev 02 | 2025/02/10 | Valid | Chemical | 2025/02/10 | Renewal|CEP granted|10/02/2025; Administrative procedure|CEP granted|07/04/2020 |
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| 1121 | Lorazepam, Micronised | LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN | 100012055;100053935 | CEP 2012-113 - Rev 01 | 2025/02/10 | Valid | Chemical | 2025/10/24 | Minor revision|Accepted - CEP remains valid|24/10/2025; Minor revision|CEP granted|10/02/2025 |
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| 542 | Busulfan | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2018-265 - Rev 01 | 2025/02/10 | Valid | Chemical | 2025/02/10 | Renewal|CEP granted|10/02/2025 | ||
| 2762 | Capecitabine | VANNSH LIFE SCIENCES PRIVATE LIMITED Visakhapatnam IN | 100048559;100080481 | CEP 2021-505 - Rev 00 | 2025/02/10 | Valid | 10/02/2030 | Chemical | 2025/02/10 | New application|CEP granted|10/02/2025 | |
| 2578 | Tizanidine hydrochloride | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2020-281 - Rev 01 | 2025/02/10 | Valid | 05/07/2028 | Chemical | 2025/02/10 | Minor revision|CEP granted|10/02/2025; New application|CEP granted|05/07/2023 |
|
| 3046 | Pemetrexed disodium 2.5-hydrate | HUZHOU ZHANWANG PHARMACEUTICAL CO., LTD. Linghu Town CN | 100014876;100032460 | CEP 2024-013 - Rev 00 | 2025/02/10 | Valid | 10/02/2030 | Chemical | 2025/02/10 | New application|CEP granted|10/02/2025 | |
| 1173 | Benserazide hydrochloride | CHEMI S.P.A. Cinisello Balsamo IT | 100000347;100004429 | CEP 2021-226 - Rev 02 | 2025/02/10 | Valid | 30/05/2028 | Chemical | 2025/02/10 | Minor revision|CEP granted|10/02/2025; Minor revision|CEP granted|13/03/2024; New application|CEP granted|30/05/2023 |
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| 1442 | Leuprorelin | HYBIO PHARMACEUTICAL CO., LTD. Shenzhen CN | 100014918;100023583 | CEP 2019-016 - Rev 01 | 2025/02/07 | Valid | Chemical | 2025/02/07 | Renewal|CEP granted|07/02/2025 | ||
| 3012 | Regorafenib monohydrate, Crystalline form | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2022-456 - Rev 00 | 2025/02/07 | Valid | 07/02/2030 | Chemical | 2025/02/07 | New application|CEP granted|07/02/2025 | |
| 2535 | Levetiracetam | SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN | 100018880;100027661 | CEP 2018-176 - Rev 01 | 2025/02/07 | Valid | Chemical | 2025/02/07 | Renewal|CEP granted|07/02/2025 | ||
| 2923 | Esomeprazole sodium | METROCHEM API PRIVATE LIMITED Hyderabad IN | 100045158;100074519 | CEP 2020-214 - Rev 02 | 2025/02/07 | Valid | 30/05/2027 | Chemical | 2025/02/07 | Minor revision|CEP granted|07/02/2025; Notification|CEP granted|21/06/2024; New application|CEP granted|30/05/2022 |
|
| 2232 | Losartan potassium | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2009-102 - Rev 06 | 2025/02/07 | Valid | Chemical | 2025/02/07 | Minor revision|CEP granted|07/02/2025; Minor revision|CEP granted|17/11/2023; Major revision|CEP granted|14/01/2022; Minor revision|CEP granted|10/03/2020 |
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