序號 | 藥物名稱 | API | CAS號 | CDE狀態 | 質量標準 | 注冊文件 |
1 | 貝前列素鈉 | Beraprost Sodium | 88475-69-8 | A Y20220001281 | JP/In-House | Local GMP DMF |
2 | 環硅酸鋯鈉 | Sodium Zirconium Cyclosilicate | 242800-27-7 | / | In-House | DMF/US-DMF(In-Process) |
3 | 替普瑞酮 | Teprenone | 6809-52-5 | A Y20220000193 | JP/In-House | Local GMP DMF |
4 | ω-3脂肪酸乙酯90 | Omega-3-acid Ethyl Ester 90 | / | A Y20190001013 | EP/USP | Local GMP CEP/US-DMF(In-Process) |
5 | 二十碳五烯酸乙酯 | Icosapent Ethyl | 86227-47-6 | A Y20210000213 | JP/In-House | Local GMP US-DMF |
6 | 精制橄欖油 | Refined Olive Oil | 8001-25-0 | A Y20210001207 | EP/USP | Local GMP DMF/CEP(In-Process) |
7 | 魚油(28% ω-3酸） | Fish Oil (28% Omega-3 Acids) | 8016-13-5 | A Y20230000280 | In-House | DMF/CEP(In-Process) |
8 | 結構甘油三脂 | Structured Triglycerides | / | I Y20250000059 | In-House | DMF |
9 | 魚油甘油三酸酯 | Fish Oil Triglycerides | / | A Y20210001075 | In-House | Local GMP DMF |
10 | ω-3 脂肪酸甘油三酯 | Omega-3-acid Triglycerides | / | / | In-House | / |
11 | 鹽酸莫西沙星 | Moxifloxacin Hydrochloride | 186826-86-8 | A Y20190009766/Y20190000446 | EP/USP | Local GMP DMF /CEP(In-Process) |
12 | 蔗糖羥基氧化鐵 | Sucroferric Oxyhydroxide | 8047-67-4 | I Y20250000537 | In-House | DMF/US-DMF(In-Process) |
13 | 異麥芽糖酐鐵 | Ferric Derisomaltose | 1345510-43-1 | / | In-House | / |
14 | 嗎啉硝唑 | Morinidazole | 92478-27-8 | A Y20220000050 | In-House | Local GMP DMF |
15 | 烏帕替尼 | Upadacitinib | 1310726-60-3 | A Y20230001341 | In-House | US-DMF |
16 | 骨化三醇 | Calcitriol | 32222-06-3 | A Y20200000975 | EP/USP | Local GMP DMF |
17 | 艾地骨化醇 | Eldecalcitol | 104121-92-8 | A Y20210000439 | In-House | Local GMP DMF |
18 | 帕立骨化醇 | Paricalcitol | 131918-61-1 | A Y20170001198 | USP | Local GMP DMF |
19 | 阿戈美拉汀 | Agomelatine | 138112-76-2 | A Y20230000472 | In-House | DMF |
20 | 度他雄胺 | Dutasteride | 164656-23-9 | A Y20210001214 | EP/USP | Local GMP DMF |
21 | 艾拉莫德 | Iguratimod | 123663-49-0 | A Y20240000438 | In-House | DMF |
22 | 利那洛肽 | Linaclotide | 851199-59-2 | I Y20240000603 | In-House | DMF/US-DMF(In-Process) |
23 | 塞來昔布 | Celecoxib | 169590-42-5 | A Y20180001644 | EP/USP | Local GMP DMF |
24 | 達格列凈 | Dapagliflozin | 461432-26-8 | A Y20210000979 | USP | DMF |
25 | 利奈唑胺 | Linezolid | 165800-03-3 | A Y20220000794 | USP | DMF |
26 | 精氨酸培哚普利 | Perindopril L-Arginine | 612548-45-5 | I Y20250000010 | EP | DMF |
27 | 羅沙司他 | Roxadustat | 808118-40-3 | A Y20230001147 | In-House | DMF |
28 | 琥珀酸索利那新 | Solifenacin Succinate | 242478-38-2 | A Y20170001548 | EP | Local GMP DMF |
29 | 多替諾雷 | Dotinurad | 1285572-51-1 | / | In-House | DMF |
30 | 艾普拉唑 | Ilaprazole | 172152-36-2 | / | In-House | DMF |
31 | 魯比前列酮 | Lubiprostone | 333963-40-9 | / | In-House | DMF |
32 | 標準桃金娘油 | Myrtle Oil | 8008-46-6 | / | In-House | DMF |
| 33 | 琥珀酰明膠 | Succinylateol Gelatin | 68915-24-2 | / | In-House | DMF |
| 34 | 加壓素 | Argipressine | 113-79-1 | / | In-House | DMF |
| 35 | 中鏈甘油三酸酯 | Medium-chain | 73398-61-5 | / | USP/EP33 | CEP(In-Process) |
| 36 | 諾西那生鈉 | Nusinersen | 1258984-36-9 | I Y20250000065 | In-House | DMF/US-DMF(In-Process) |
中間體 Intermediate | ||||||
1 | GalNAc（L96) | / | In-House | / | ||
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