Formosa Laboratories, Inc.

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
Gadobutrol Monohydrate	DMF # 036660; date of submission: Dec. 30, 2021
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 15)

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
Nintedanib Esylate	DE: #4839 NL: #04351
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 DK: #2215-3145 ES: AA/0093/21 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 SI: 1410-43/2021 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 12)

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 16)

Substance	DMF number
Alfacalcidol	Y20170000266
Benzonatate	Y20190000653
Calcipotriol Anhydrous	Y20170001615
Calcipotriol Monohydrate	Y20200000431
Calcitriol	Y20190021431
Capsaicin	Y20220000873
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 5)

Substance	DMF number
Benzonatate	015:1425
Montelukast Sodium	015:937
Pazopanib Hydrochloride	015:1688
Sevelamer Carbonate	015:1240
Temozolomide	015:831