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 |
---|---|---|---|---|---|---|---|---|---|---|---|
2422 | Oseltamivir phosphate, Form-A | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2018-046 - Rev 02 | 2025/05/09 | Valid | Chemical | 2025/05/09 | Renewal|CEP granted|09/05/2025; Minor revision|CEP granted|25/09/2023; Minor revision|Accepted - CEP remains valid|05/01/2022 |
||
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 | 2025/05/09 | New application|CEP granted|09/05/2025 | |
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 | |
1681 | Tramadol hydrochloride, Process-III | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2025-016 - 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 |
||
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 |
||
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 |
||
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 |
||
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 |
||
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 |
||
2203 | Citalopram hydrochloride, Process II | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2019-233 - Rev 02 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025; Notification|CEP granted|29/07/2024 |