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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Chemo Iberica Sa to the U.S. FDA. Original Data : FDA Website

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01 ALISKIREN HEMIFUMARATE (1)

02 ASENAPINE MALEATE (1)

03 ISRADIPINE (1)

04 LANSOPRAZOLE (PROCESS II) (1)

05 LANSOPRAZOLE USP (1)

06 LEVOFLOXACIN (1)

07 NINTEDANIB ESYLATE (1)

08 Nedocromil Disodium (1)

09 PIRFENIDONE (1)

10 RABEPRAZOLE SODIUM (PROCESS I) (1)

11 RABEPRAZOLE SODIUM (PROCESS II) (1)

12 RANOLAZINE (1)

13 SEVELAMER CARBONATE (2)

14 SEVELAMER HYDROCHLORIDE (1)

15 TAMSULOSIN HYDROCHLORIDE (1)

16 TIANEPTINE SODIUM (1)

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01 CHEMO IBERICA SA (6)

02 CHEMO IBERICA SA MADRID (3)

03 CHEMO SMS ENTERPRISE SL (1)

04 QUIMICA SINTETICA SA (7)

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01 Spain (17)

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01 Active (10)

02 Inactive (7)

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01 Complete (8)

02 Blank (9)

URL Supplier Web Content
CHEMO IBERICA SA
Inactive
26776
N/A
2012-12-27
II
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CHEMO IBERICA SA
Inactive
27290
N/A
2013-07-08
II
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QUIMICA SINTETICA SA
Active
17367
Complete
2014-10-10
2014-03-20
2004-05-05
II
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QUIMICA SINTETICA SA
Active
29462
Complete
2016-03-08
2015-08-07
2015-06-26
II
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QUIMICA SINTETICA SA
Active
24487
Complete
2014-01-17
2013-09-27
2010-12-23
II
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QUIMICA SINTETICA SA
Active
28920
Complete
2015-06-01
2015-03-16
2014-12-15
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CHEMO IBERICA SA MADR...
Inactive
21169
N/A
2007-12-19
II
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CHEMO IBERICA SA
Active
39158
N/A
2023-11-22
II
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CHEMO IBERICA SA
Active
32796
Complete
2018-10-04
2018-05-31
2018-05-18
II
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CHEMO IBERICA SA MADR...
Inactive
21585
N/A
2008-04-30
II
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