No. | API | CAS No. | CDE Status | Specificatoion | Registration Files |
1 | Beraprost Sodium | 88475-69-8 | A Y20220001281 | JP/In-House | Local GMP DMF |
2 | Sodium Zirconium Cyclosilicate | 242800-27-7 | / | In-House | DMF/US-DMF(In-Process) |
3 | Teprenone | 6809-52-5 | A Y20220000193 | JP/In-House | Local GMP DMF |
4 | Omega-3-acid Ethyl Ester 90 | / | A Y20190001013 | EP/USP | Local GMP CEP/US-DMF(In-Process) |
5 | Icosapent Ethyl | 86227-47-6 | A Y20210000213 | JP/In-House | Local GMP US-DMF |
6 | Purified Olive Oil | 8001-25-0 | A Y20210001207 | EP/USP | Local GMP DMF/CEP(In-Process) |
7 | Fish Oil (28% Omega-3 Acids) | 8016-13-5 | A Y20230000280 | In-House | DMF/CEP(In-Process) |
8 | Structured Triglycerides | / | I Y20250000059 | In-House | DMF |
9 | Fish Oil Triglycerides | / | A Y20210001075 | In-House | Local GMP DMF |
10 | Omega-3-acid Triglycerides | / | / | In-House | / |
11 | Moxifloxacin Hydrochloride | 186826-86-8 | A Y20190009766/Y20190000446 | EP/USP | Local GMP DMF/CEP(In-Process) |
12 | Sucroferric Oxyhydroxide | 8047-67-4 | I Y20250000537 | In-House | DMF/US-DMF(In-Process) |
13 | Ferric Derisomaltose | 1345510-43-1 | / | In-House | / |
14 | Morinidazole | 92478-27-8 | A Y20220000050 | In-House | Local GMP DMF |
15 | Upadacitinib | 1310726-60-3 | A Y20230001341 | In-House | US-DMF |
16 | Calcitriol | 32222-06-3 | A Y20200000975 | EP/USP | Local GMP DMF |
17 | Eldecalcitol | 104121-92-8 | A Y20210000439 | In-House | Local GMP DMF |
18 | Paricalcitol | 131918-61-1 | A Y20170001198 | USP | Local GMP DMF |
19 | Agomelatine | 138112-76-2 | A Y20230000472 | In-House | DMF |
20 | Dutasteride | 164656-23-9 | A Y20210001214 | EP/USP | Local GMP DMF |
21 | Iguratimod | 123663-49-0 | I Y20240000438 | In-House | DMF |
22 | Linaclotide | 851199-59-2 | I Y20240000603 | In-House | DMF/US-DMF(In-Process) |
23 | Celecoxib | 169590-42-5 | A Y20180001644 | EP/USP | Local GMP DMF |
24 | Dapagliflozin | 461432-26-8 | A Y20210000979 | USP | DMF |
25 | Linezolid | 165800-03-3 | A Y20220000794 | USP | DMF |
26 | Perindopril L-Arginine | 612548-45-5 | I Y20250000010 | EP | DMF |
27 | Roxadustat | 808118-40-3 | A Y20230001147 | In-House | DMF |
28 | Solifenacin Succinate | 242478-38-2 | A Y20170001548 | EP | Local GMP DMF |
29 | Dotinurad | 1285572-51-1 | / | In-House | DMF |
30 | Ilaprazole | 172152-36-2 | / | In-House | DMF |
31 | Lubiprostone | 333963-40-9 | / | In-House | DMF |
32 | Myrtle Oil | 8008-46-6 | / | In-House | DMF |
33 | Succinylateol Gelatin | 68915-24-2 | / | In-House | DMF |
34 | Argipressine | 113-79-1 | / | In-House | DMF |
35 | Medium-chain Triglycerides | 73398-61-5 | / | USP/EP | CEP(In-Process) |
36 | Nusinersen | 1258984-36-9 | I Y20250000065 | In-House | DMF/US-DMF(In-Process) |
Intermediates | |||||
1 | GalNAc(L96) | / | / | In-House | / |
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