| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2234 | Meropenem trihydrate, Sterile, synthetic origin, process II | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2018-268 - Rev 02 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Renewal|CEP granted|28/10/2025; Minor revision|CEP granted|19/12/2022 |
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| 2179 | Pimobendan for Veterinary Use | WISDOM PHARMACEUTICAL CO., LTD. Haimen CN | 100014837;100023467 | CEP 2013-329 - Rev 01 | 2025/10/27 | Valid | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Minor revision|Accepted - CEP remains valid|29/06/2021; Renewal|CEP granted|03/05/2021; Minor revision|Accepted - CEP remains valid|30/10/2020 |
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| 1961 | Poly(vinyl alcohol), Viscosity 5.1 mPa.s, Ester value 140 mg KOH/g | MITSUBISHI CHEMICAL CORPORATION Chiyoda JP | 100047136;100077835 | CEP 2013-209 - Rev 01 | 2025/10/27 | Valid | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Renewal|CEP granted|28/09/2021; Administrative procedure|CEP granted|13/01/2020 |
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| 977 | Brompheniramine maleate | SUPRIYA LIFESCIENCE LIMITED Mumbai IN | 100015796;100024574 | CEP 2015-097 - Rev 02 | 2025/10/27 | Valid | Chemical | 2025/10/27 | Administrative procedure|CEP granted|27/10/2025; Major revision|CEP granted|14/05/2025; Renewal|CEP granted|19/01/2023 |
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| 2191 | Atorvastatin calcium, Form-I | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | CEP 2021-150 - Rev 02 | 2025/10/27 | Valid | 18/01/2028 | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Minor revision|Accepted - CEP remains valid|28/06/2024; Administrative procedure|CEP granted|28/03/2023; New application|CEP granted|19/01/2023 |
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| 2631 | Rosuvastatin calcium, RS02 | CTX LIFESCIENCES PVT. LIMITED Surat IN | 100019102;100027863 | CEP 2025-419 - Rev 00 | 2025/10/27 | Valid | 27/10/2030 | Chemical | 2025/10/27 | New application|CEP granted|27/10/2025 | |
| 2230 | Latanoprost | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2024-162 - Rev 01 | 2025/10/27 | Valid | 17/09/2030 | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; New application|CEP granted|17/09/2025 |
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| 2778 | Sitagliptin phosphate monohydrate | IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN | 100017919;100037377 | CEP 2024-063 - Rev 00 | 2025/10/27 | Valid | 27/10/2030 | Chemical | 2025/10/27 | New application|CEP granted|27/10/2025 | |
| 2449 | Docetaxel trihydrate | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2022-149 - Rev 02 | 2025/10/27 | Valid | 07/03/2029 | Chemical | 2025/10/27 | Minor revision|CEP granted|27/10/2025; Minor revision|CEP granted|15/11/2024; New application|CEP granted|07/03/2024 |
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| 1656 | Moxidectin for veterinary use, with butyl hydroxytoluene | HISUN PHARMACEUTICAL (HANGZHOU) CO., LTD. Hangzhou City CN | 100012542;100060684 | CEP 2012-384 - Rev 03 | 2025/10/24 | Valid | Chemical | 2025/10/24 | Minor revision|CEP granted|24/10/2025; Minor revision|CEP granted|13/12/2021 |
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| 1794 | Paclitaxel, Produced by a semi-synthetic process | CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN | 100041836;100068984 | CEP 2022-006 - Rev 01 | 2025/10/24 | Valid | 07/02/2028 | Chemical | 2025/10/24 | Minor revision|CEP granted|24/10/2025; New application|CEP granted|07/02/2023 |
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| 2420 | Tiotropium bromide monohydrate, Micronised, non-micronised | Inke, S.A. Castellbisbal ES | 100020253;100029013 | CEP 2019-337 - Rev 02 | 2025/10/24 | Valid | Chemical | 2025/10/24 | Renewal|CEP granted|24/10/2025; Minor revision|CEP granted|16/05/2023 |
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| 1524 | Gliclazide | SHANDONG HAIYOU FREDA PHARMACEUTICAL CO. LTD. Linyi CN | 100043655;100072192 | CEP 2024-434 - Rev 00 | 2025/10/24 | Valid | 24/10/2030 | Chemical | 2025/10/24 | New application|CEP granted|24/10/2025 | |
| 2604 | Ropinirole hydrochloride | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2021-240 - Rev 01 | 2025/10/22 | Valid | 31/10/2029 | Chemical | 2025/10/22 | Major revision|CEP granted|22/10/2025; New application|CEP granted|31/10/2024 |
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| 1768 | Valaciclovir hydrochloride, Process B | ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN | 100011826;100018693 | CEP 2024-169 - Rev 02 | 2025/10/22 | Valid | 25/09/2029 | Chemical | 2025/10/22 | Administrative procedure|CEP granted|22/10/2025; Minor revision|CEP granted|08/10/2025; New application|CEP granted|25/09/2024 |
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| 3087 | Ticagrelor | Zhejiang Supor Pharmaceuticals Co., Ltd. Shaoxing CN | 100022886;100031604 | CEP 2023-374 - Rev 00 | 2025/10/22 | Valid | 22/10/2030 | Chemical | 2025/10/22 | New application|CEP granted|22/10/2025 | |
| 1002 | Diclofenac sodium | HENAN DONGTAI PHARM CO., LTD. Anyang CN | 100023192;100052097 | CEP 2014-009 - Rev 01 | 2025/10/22 | Valid | Chemical | 2025/10/22 | Major revision|CEP granted|22/10/2025; Renewal|CEP granted|21/12/2020; Major revision|CEP granted|03/06/2020 |
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| 2217 | Lamivudine, SVL Process | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2014-034 - Rev 05 | 2025/10/22 | Valid | Chemical | 2025/10/22 | Notification|CEP granted|22/10/2025; Transfer of holdership|CEP granted|25/07/2024; Minor revision|CEP granted|28/03/2024; Minor revision|CEP granted|30/08/2022; Major revision|CEP granted|16/11/2020 |
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| 1508 | Diclofenac potassium | HENAN DONGTAI PHARM CO., LTD. Anyang CN | 100023192;100052097 | CEP 2014-031 - Rev 01 | 2025/10/22 | Valid | Chemical | 2025/10/22 | Major revision|CEP granted|22/10/2025; Renewal|CEP granted|08/03/2021; Major revision|CEP granted|03/06/2020 |
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| 2757 | Aprepitant | WISDOM PHARMACEUTICAL CO., LTD. Haimen CN | 100014837;100023467 | CEP 2019-117 - Rev 01 | 2025/10/22 | Valid | Chemical | 2025/10/22 | Renewal|CEP granted|22/10/2025 |
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