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Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Urquima S.a. Grupo Uriach to the U.S. FDA. Original Data : FDA Website

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01 ALBACONAZOLE (1)

02 AZELASTINE HCL (1)

03 CARVEDILOL, MICRONIZED (1)

04 FACILITIES AND OPERATING PROCEDURES IN BARCELONA, SPAIN. (1)

05 FLUTRIMAZOLE (1)

06 GLIMEPIRIDE, MICRONISED (1)

07 GLIPIZIDE (1)

08 IVABRADINE HYDROCHLORIDE (FORM IV) (1)

09 OLOPATADINE HYDROCHLORIDE (1)

10 ROPINIROLE HYDROCHLORIDE (1)

11 RUPATADINE FUMARATE (1)

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01 URQUIMA SA (11)

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01 Spain (11)

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01 Active (5)

02 Inactive (6)

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01 Complete (3)

02 Blank (8)

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URQUIMA SA
Inactive
28242
N/A
2014-05-14
II
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URQUIMA SA
Active
20314
Complete
2013-05-21
2013-05-10
2007-02-12
II
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URQUIMA SA
Inactive
18158
N/A
2005-03-11
II
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URQUIMA SA
Inactive
12806
N/A
1997-12-24
II
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URQUIMA SA
Inactive
18396
N/A
2005-06-03
II
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URQUIMA SA
Active
10046
N/A
1993-01-19
II
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URQUIMA SA
Active
33213
Complete
2019-03-01
2018-10-19
2018-10-15
II
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URQUIMA SA
Active
19417
Complete
2013-09-14
2013-09-04
2006-05-09
II
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URQUIMA SA
Inactive
17880
N/A
2004-12-08
II
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URQUIMA SA
Active
36047
N/A
2021-08-09
II
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