PRODUCT | PHARMACOPOEIA | REGULATORY STATUS | ||
---|---|---|---|---|
US DMF | CEP | OTHERS | ||
ANTI FUNGAL | ||||
Ketoconazole | USP/BP/EP/IP | NDC No.: 60524-005-01 | CEP 2011-137 | "Korea DMF No.: 20120413- 167-I-46-01 TDMF (Taiwan): DMF(20)1116" |
Miconazole Nitrate | USP/BP/EP/IP | NDC No.: 60524-012-01 | — | Open Part DMF |
Sertaconazole Nitrate | BP/EP | -- | -- | Open Part DMF |
CARDIOVASCULAR | ||||
Trimetazidine Di HCl | BP/EP/JP/IP | N/A | "RO-CEP 2010- 075 REV 03" | "Russia ND No. : FS 000 217 - 241011 Ukraine Reg. No.: UA/6122-01-01 Technical Package & Open Part DMF" |
Nifedipine | USP/BP/EP/IP | NDC No.: 60524-008-01 | — | TFDA (Taiwan): 1036045916 Open Part DMF |
ANTI DEPRESSANT | ||||
Atomoxetine HCl | In-House/USP | — | — | Open Part DMF |
Trazodone HCl | BP/USP | — | ASMF Filed | Open Part DMF |
ANTI ALZHEIMER | ||||
Memantine HCI | In-House/USP | NDC No.: 60524-006-01 | ASMF Filed | Open Part DMF |
MUSCLE RELAXANT | ||||
Eperisone HCl | JP | — | — | "Korea DMF No.: 2013205-46-C-306-08 Open Part DMF" |
ANTI DIABETIC | ||||
Glimepiride | USP/BP/EP/IP | — | — | "Korea DMF No. : 2013507-78-D-122-18 Taiwan DMF No.: DMF (20) 0207 Ukraine Reg. No.: UA/11427-01-01 Open Part DMF" |
G.I. PRO-KINETIC | ||||
Mosapride Citrate Dihydrate | IP/In-House/JP | — | — | "TDMF (Taiwan) : DMF(20)1877 KDMF (Korea) Open Part DMF" |
ANTI PSYCHOTIC | ||||
Aripiprazole | USP/In-House | — | ASMF Filed | Open Part DMF |
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