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品質方針 
DMFs & CEPs 

US DMF (total 49) 

Substance DMF number
Anastrozole DMF # 020282; date of submission: Feb. 15, 2007
Avobenzone DMF # 017755; date of submission: Oct. 12, 2004 
Balsalazide DMF # 017326; date of submission: Apr. 19, 2004 
Benzonatate DMF # 021703; date of submission: Jun. 16, 2008
Calcifediol DMF # 033640; date of submission: May. 03, 2019
Calcipotriol DMF # 019415; date of submission: Mar. 31, 2006
Calcipotriol Monohydrate DMF # 023267; date of submission: Nov. 13, 2009
Calcitriol DMF # 018227; date of submission: Mar. 21, 2005
Calcium Acetate DMF # 023735; date of submission: Apr. 21, 2010
Capsaicin DMF # 016769; date of submission: Aug. 18, 2003
Colesevelam HCl DMF # 022870; date of submission: Jun. 16, 2009
DMF # 030001; date of submission: Nov. 13, 2015
Colestipol HCl DMF # 017651; date of submission: Sep. 02, 2004
DDAIP DMF # 019586; date of submission: May 18, 2006
Dinalbuphine Sebacate DMF # 032476; date of submission: Mar. 22, 2018
Doxercalciferol DMF # 022136; date of submission: Oct. 31, 2008
Elagolix Sodium DMF # 034907; date of submission: Jun. 30, 2020
Ergocalciferol DMF # 024189; date of submission: Sep. 20, 2010
Eribulin Mesylate DMF # 035358; date of submission: Nov. 30, 2020
Ferric Carboxymaltose DMF # 035442; date of submission: Dec. 31, 2020
Fondaparinux Sodium DMF # 027475; date of submission: Sep. 17, 2013
Gadoterate Meglumine DMF # 034129; date of submission: Sep. 12, 2019
Iloperidone DMF # 024481; date of submission: Dec. 22, 2010
Imatinib Mesylate DMF # 035153; date of submission: Oct. 20, 2020
Ixabepilone DMF # 025894; date of submission: Apr. 03, 2012
Lapatinib Ditosylate DMF # 024788; date of submission: Mar. 18, 2011
Leflunomide DMF # 016038; date of submission: Jun. 27, 2002
Levonorgestrel DMF # 021634; date of submission: May 20, 2008 
Linezolid DMF # 025700; date of submission: Jan. 09, 2012
Mifepristone DMF #027474; date of submission: Sep. 13, 2013
Mycophenolate Sodium DMF # 024397, date of submission: Nov. 19, 2010
Mycophenolate Mofetil DMF # 022046; date of submission: Oct. 02, 2008 
Meprobamate DMF # 020465; date of submission: Apr. 23, 2007 
Montelukast DMF # 021702; date of submission: Jun. 16, 2008 
Mycophenolic Acid DMF # 021952; date of submission: Sep. 05, 2008 
Nintedanib DMF # 032408; date of submission: Jan. 05, 2018 
Nintedanib Esylate DMF # 032643; date of submission: Apr. 02, 2018 
Orlistat DMF # 023978; date of submission: Jul. 19, 2010
Paricalcitol DMF # 021880; date of submission: Aug. 14, 2008 
Patiromer Sorbitex Calcium DMF # 032966; date of submission: Jun. 06, 2019 
Pazopanib Hydrochloride DMF # 031297; date of submission: Jan. 03, 2017
Rucaparib Camsylate DMF # 034419; date of submission: Dec. 26, 2019
Sevelamer Carbonate DMF # 23039; date of submission: Aug. 13, 2009
DMF # 030002; date of submission: Nov. 13, 2015
Sevelamer HCl DMF # 22631; date of submission: Mar. 16, 2009
Temozolomide DMF # 23158; date of submission: Oct. 06, 2009
Teriflunomide DMF # 029862; date of submission: Dec. 31, 2015
Ulipristal Acetate DMF # 25701; date of submission: Jan. 09, 2012
 

CEP (total 8)

Substance CEP number
Calcifediol Monohydrate CEP2019-163
Calcipotriol Anhydrous CEP2007-243
Calcipotriol Monohydrate CEP2010-187
Calcitriol CEP2009-377
CEP2020-150
Leflunomide CEP2009-035
Montelukast Sodium CEP2013-278
Temozolomide CEP2017-245
 

EU DMF (total 14)

Substance DMF number
Alfacalcidol Italy: # 8906.13235.405
Greece: # 791
Capsaicin Greece: # 1714
DE: #3723
UK: MFD-31818-1-06807
ES: AA/01334/18
Colesevelam Hydrochloride UK: # MFD-31818-2-07236
DE: #4427
Gadoterate Meglumine DE: #4616
GR: #3768
Linezolid AT: #551157
CZ: sukls20988/2015
DE: #3266
DK: #2215-2184
ES: AA/0128/13 ; AA/0111/14
FR: #2013-081 ; #2014-038
HR: # 530-09/13-12/83
IT: AIN/2014/20 ; AIN/2017/1445
NL: #02793
PL: UR.DOL.OLC.4003.0302.2014 ; UR.DOL.OLC.4003.0028.2015
UK: MFD-31818-1-00575-0003
Montelukast Sodium AT: #551116
CZ: # sukls10917/2014
HR: #530-09/13-12/90
NL: #021165
UK: # MFD-31818-2-07158
Mycophenolate Mofetil DE: #4599
UK: MFD-31818-2-07706
Orlistat AT: ASMF12112
CZ: sukls103875/2013
DK: #2215-2045/201206-0834
ES: OW/3266/12
HR: #530-09/13-12/12
NL: #02581
NO: 12/5913
PL: UR.DOL.OLC.4003.0125.2012
SE: 2012/103
UK: MFD-31818-1-02752-0001
Paricalcitol AT: #550388
CZ: sukls210751/2013
DE: #3137
DK: #2215-1772
ES: PW/2816/10
GR: #2451
HU: OGYI/33693-2/2010
IT: AIN/2014/19
NL: #02744
PL: UR.DOL.OLC.4003.0284.2015
Pazopanib Hydrochloride CZ: sukls314155/2020
DE: #4526
ES: #AA/0167/20
GR: #3690
IT:  AIN/2020/2469
LA: LV/H/DMF/20/0046
LT: 2020/0701/LT
HR: 530-09/20-12/73
SE: 2020/139
PT: 134/2020
NL: 04024
FR: 2020-109
UK: MFD-31818-2-09969
HU: OGYÉI/73277/2020
SI: 1410-58/2020
Sevelamer Carbonate AT: #550953
BE: #154182
CZ: Sukls213208/2018
DE: #3095
DK: #2215-1765
ES: CS/3324/12
FR: #2021-068
GR: 91008/30-09-2021
HU: OGY/33444-1/2010
HR: #530-09/13-12/67
IT: AIN/2016/612
NL: #02651
PL: UR.DOL.OLC.4003.0224.2017
SE: #2012/090
UK: MFD-31818-2-14239-0003 
 
Temozolomide DE: #3312
IT: AIN/2014/21
NL: #02854
CZ: sukls372363/2017
DK: #2215-2789
HU: OGYEI/69716-1/2017
HR: HALMED-MF-11773(530-09/17-12/63)
Teriflunomide AT: 552542
BE: 309834
CY: 2021-DMF-1787
CZ: sukls241852/2021
DE: #4619
ES: AA/0140/21
FR: 2021-055
GR: 78582/26-08-2021
HR: 530-09/21-12/47
IE: 22500006
IT: AIN/2021/1855
LT: 2021/0778/LT
LV: LV/H/DMF/21/0029
NL: #04134
UK: MFD-31818-1-11101
Nonivamide DE: #4166
LV: LV/H/DMF/20/0042
LT: 2020/0695/LT
 

Japan DMF (total 14)

Substance DMF number
Alfacalcidol 302MF10045
Gadodiamide 220MF10205
Tegaful 224MF10136
Gimeracil 224MF10135
Oteracil Potassium 224MF10134
Taltirelin hydrate 224MF10029
303MF10035
Linezolid 225MF10170
226MF10166(oral)
302MF10099
Maxacalcitol 226MF10138
Temozolomide 228MF10143
Levonorgestrel 228MF10159
Calcitriol 228MF10187
 

Canada DMF (total 11)

Substance DMF number
Calcipotriol Anhydrous 2013-137
Calcitriol 2001-124
Capsaicin 2016-181
Colesevelam Hydrochloride 2021-054
Leflunomide 2003-135
Linezolid 2013-118
Pazopanib Hydrochloride 2021-104
Sevelamer Carbonate 2017-009
2021-122
Sevelamer Hydrochloride 2021-083
Temozolomide 2014-124
Teriflunomide 2018-236
 

Australia DMF (total 5)

Substance DMF number
Linezolid  DMF #2014/001920
Montelukast Sodium DMF #2014/008203
Mycophenolate Mofetil DMF #D21‐3214450
Sevelamer Carbonate DMF# 17-0072
Teriflunomide DMF# 17-0253


New Zealand DMF (total 2)

Substance DMF number
Leflunomide TT60-905-18/1
Paricalcitol TT60-905-18-3
 

Russia DMF (total 3)

Substance DMF number
Leflunomide LSR-005818/09
Temozolomide FC-000605
Mycophenolate Mofetil FC-000467


China DMF (total 15)

Substance DMF number
Alfacalcidol Y20170000266
Benzonatate Y20190000653
Calcipotriol Anhydrous Y20170001615
Calcipotriol Monohydrate Y20200000431
Calcitriol Y20190021431
Colesevelam Hydrochloride Y20190000469
Flupentixol Dihydrochloride JXHL1300425國
Gadoterate Meglumine Y20200000802
Linezolid Y20190000467
Melitracen Hydrochloride JXHL1300424國
Montelukast Sodium Y20170001580
Paricalcitol Y20180000002
Pazopanib Hydrochloride Y20190021452
Sevelamer Carbonate Y20180001514
Temozolomide Y20170000140
 

Singapore DMF (total 4)

Substance DMF number
Benzonatate 015:1425
Montelukast Sodium 015:937
Sevelamer Carbonate 015:1240
Temozolomide 015:831

 



 
 
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