| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1200 | Dobutamine hydrochloride | D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN | 100023552;100032697 | CEP 2023-369 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 1240 | Mefenamic acid, Solara | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2025-076 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/12/22 | Minor revision|Rejected|22/12/2025; New application|CEP granted|09/05/2025 |
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| 2778 | Sitagliptin phosphate monohydrate, Process-II | CHEMO SMS ENTERPRISE, SL Madrid ES | 100038838;100060977 | CEP 2025-049 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 2577 | Oxcarbazepine, Code 1138 milled grade | F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT | 100011866;100022277 | CEP 2025-115 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 2856 | Pirfenidone | SNJ LABS PRIVATE LIMITED Dist. Rajkot IN | 100051266;100089774 | CEP 2024-165 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 810 | Betamethasone sodium phosphate | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2023-440 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 1096 | Doxepin hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-197 - Rev 05 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Minor revision|CEP granted|07/05/2025; Minor revision|Accepted - CEP remains valid|26/06/2023; Minor revision|CEP granted|08/12/2021; Minor revision|Accepted - CEP remains valid|12/06/2020 |
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| 1120 | Lisinopril dihydrate | RICHTER THEMIS MEDICARE (I) PVT. LTD. Vapi IN | 100012132;100018972 | CEP 2018-223 - Rev 01 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025 | ||
| . | Foetal Calf Serum, Defined, characterised, standard | HYCLONE LABORATORIES LLC. Logan US | 100012797;100022115 | CEP 2000-076 - Rev 06 | 2025/05/07 | Valid | TSE | 2025/05/07 | Notification|CEP granted|07/05/2025; Major revision|CEP granted|06/07/2022; Notification|Rejected|25/03/2022; Notification|Accepted - CEP remains valid|23/03/2021; Notification|Accepted - CEP remains valid|27/08/2020; Notification|CEP granted|24/06/2020 |
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| 1705 | Sertraline hydrochloride, Alternate process | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2012-218 - Rev 05 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Minor revision|CEP granted|07/05/2025; Minor revision|Accepted - CEP remains valid|04/10/2023; Minor revision|Accepted - CEP remains valid|17/02/2023; Minor revision|CEP granted|07/09/2022 |
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| 816 | Cinnarizine | FLEMING LABORATORIES LIMITED Nawabpet Village IN | 100015641;100024384 | CEP 2015-019 - Rev 01 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Monograph revision|CEP granted|07/05/2025; Renewal|CEP granted|10/05/2022; Minor revision|Accepted - CEP remains valid|03/02/2021 |
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| 888 | Ciprofloxacin Hydrochloride, Process 105 | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN | 100022562;100093113 | CEP 2019-007 - Rev 05 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025; Minor revision|CEP granted|29/10/2024; Minor revision|CEP granted|26/06/2023; Minor revision|CEP granted|16/08/2024; Notification|Rejected|23/01/2023; Minor revision|CEP granted|01/08/2022 |
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| 2849 | Hydroxychloroquine sulfate | MANGALAM DRUGS & ORGANICS LTD. Mumbai IN | 100012477;100021137 | CEP 2019-151 - Rev 02 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025; Notification|CEP granted|19/07/2024 |
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| 2600 | Olmesartan medoxomil, Process II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2020-112 - Rev 04 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025; Notification|CEP granted|11/01/2024; Minor revision|CEP granted|05/06/2023; Minor revision|CEP granted|19/08/2022; New application|CEP granted|31/07/2020 |
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| 1335 | Itraconazole | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2011-283 - Rev 01 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; Minor revision|Rejected|21/02/2025 |
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| 2126 | Cefepime dihydrochloride monohydrate, Sterile | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2011-286 - Rev 02 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Major revision|CEP granted|05/05/2025; Major revision|CEP granted|21/12/2021 |
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| 2306 | Gemcitabine hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2008-161 - Rev 03 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Notification|CEP granted|05/05/2025; Notification|CEP granted|20/12/2021; Notification|Accepted - CEP remains valid|22/02/2021 |
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| 394 | Hydrochlorothiazide | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2001-304 - Rev 13 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; Notification|Accepted - CEP remains valid|20/02/2023; Minor revision|CEP granted|03/10/2022; Minor revision|CEP granted|01/12/2021; Minor revision|CEP granted|09/12/2020 |
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| 1058 | Vancomycin hydrochloride | CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN | 100011996;100039007 | CEP 2018-197 - Rev 01 | 2025/05/05 | Valid | Chemical and TSE | 2025/05/05 | Renewal|CEP granted|05/05/2025 | ||
| 1551 | Nomegestrol acetate, Nomac grade B | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2014-178 - Rev 06 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; Minor revision|CEP granted|25/09/2024; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|22/10/2021; Minor revision|CEP granted|10/07/2020; Monograph revision|CEP granted|06/05/2020 |
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