| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015 | Ebastine | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2009-106 - Rev 04 | 2025/05/13 | Valid | Chemical | 2025/05/13 | Minor revision|CEP granted|13/05/2025; Minor revision|CEP granted|13/07/2023 |
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| 2733 | Escitalopram oxalate, Process I | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2016-306 - Rev 01 | 2025/05/13 | Valid | Chemical | 2025/05/13 | Minor revision|CEP granted|13/05/2025; Renewal|CEP granted|23/05/2023; Minor revision|CEP granted|28/10/2020 |
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| 2778 | Sitagliptin phosphate monohydrate | MOREPEN LABORATORIES LIMITED Baddi IN | 100017843;100026642 | CEP 2019-040 - Rev 01 | 2025/05/13 | Valid | Chemical | 2025/05/13 | Renewal|CEP granted|13/05/2025 | ||
| 1710 | Bisoprolol fumarate | MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN | 100023732;100032901 | CEP 2018-209 - Rev 01 | 2025/05/13 | Valid | Chemical | 2025/05/13 | Renewal|CEP granted|13/05/2025 | ||
| 2740 | Sodium selenite | RETORTE GMBH SELENIUM CHEMICALS & METALS Röthenbach DE | 100026545;100042398 | CEP 2018-129 - Rev 02 | 2025/05/13 | Valid | Chemical | 2025/05/13 | Minor revision|CEP granted|13/05/2025; Renewal|CEP granted|15/02/2024 |
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| 2782 | Vardenafil hydrochloride trihydrate | SMS PHARMACEUTICALS LIMITED Hyderabad IN | 100011780;100061058 | CEP 2018-202 - Rev 02 | 2025/05/13 | Valid | Chemical | 2025/05/13 | Renewal|CEP granted|13/05/2025; Minor revision|CEP granted|04/04/2024 |
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| . | Collagen Peptide | SICHUAN RAYBO BIOTECHNOLOGY CO. LTD. Guanghan CN | 100054197;100095911 | CEP 2019-322 - Rev 01 | 2025/05/13 | Valid | TSE | 2025/05/13 | Renewal|CEP granted|13/05/2025 | ||
| 2675 | Irinotecan hydrochloride trihydrate | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2023-338 - Rev 00 | 2025/05/13 | Valid | 13/05/2030 | Chemical | 2025/05/13 | New application|CEP granted|13/05/2025 | |
| 2593 | Docetaxel | CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN | 100041836;100068984 | CEP 2022-295 - Rev 01 | 2025/05/13 | Valid | 28/09/2028 | Chemical | 2025/05/13 | Minor revision|CEP granted|13/05/2025; New application|CEP granted|28/09/2023 |
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| 2422 | Oseltamivir phosphate, Form-A | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2018-046 - Rev 02 | 2025/05/09 | Valid | Chemical | 2026/02/27 | Minor revision|Accepted - CEP remains valid|27/02/2026; Renewal|CEP granted|09/05/2025; Minor revision|CEP granted|25/09/2023; Minor revision|Accepted - CEP remains valid|05/01/2022 |
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| 2577 | Oxcarbazepine | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2022-458 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 1681 | Tramadol hydrochloride | SUPRIYA LIFESCIENCE LIMITED Mumbai IN | 100015796;100024574 | CEP 2023-203 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 2857 | Trazodone hydrochloride | BAJAJ HEALTHCARE LIMITED Thane IN | 100021782;100061986 | CEP 2023-228 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 1717 | Desogestrel | NEWCHEM S.p.A. Milano IT | 100017847;100080332 | CEP 2023-246 - Rev 00 | 2025/05/09 | Valid | 09/05/2030 | Chemical | 2025/05/09 | New application|CEP granted|09/05/2025 | |
| 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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| 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 | |
| 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 |
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