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

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01 ASTEMIZOLE (1)

02 ATRACURIUM BESYLATE USP (1)

03 BENAZEPRIL HYDROCHLORIDE USP (1)

04 CAPTOPRIL (1)

05 CISATRACURIUM BESYLATE USP (1)

06 CROMOLYN SODIUM (1)

07 DECITABINE (1)

08 DEUTETRABENAZINE (1)

09 ENALAPRIL MALEATE (1)

10 EVEROLIMUS (2.0% BHT) (1)

11 FEXOFENADINE HYDROCHLORIDE (1)

12 FH-109 (MOEXIPRIL HYDROCHLORIDE) (1)

13 FH-113 (RAMIPRIL) (1)

14 LISINOPRIL USP (1)

15 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. (1)

16 METFORMIN HYDROCHLORIDE (1)

17 METFORMIN HYDROCHLORIDE + 0.5% MAGNESIUM STEARATE (1)

18 METFORMIN HYDROCHLORIDE / 0.75% COLLOIDAL SILICON DIOXIDE BLEND (1)

19 MILRINONE (1)

20 QUINAPRIL HYDROCHLORIDE (1)

21 ROCURONIUM BROMIDE USP (1)

22 SUGAMMADEX SODIUM (1)

23 TACROLIMUS USP (1)

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01 FARMHISPANIA SA (23)

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01 Spain (23)

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01 Active (17)

02 Inactive (6)

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01 Complete (7)

02 Blank (16)

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FARMHISPANIA SA
Inactive
12179
N/A
1996-10-22
II
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FARMHISPANIA SA
Active
11607
Complete
2022-02-01
2022-01-27
1995-07-31
II
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FARMHISPANIA SA
Active
15457
Complete
2020-03-20
2020-03-18
2001-05-04
II
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FARMHISPANIA SA
Inactive
9269
N/A
1991-07-31
II
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FARMHISPANIA SA
Active
24999
Complete
2020-04-14
2020-04-09
2011-05-30
II
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FARMHISPANIA SA
Inactive
11050
N/A
1994-08-26
II
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FARMHISPANIA SA
Active
34163
N/A
2019-10-08
II
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FARMHISPANIA SA
Active
37341
N/A
2022-08-02
II
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FARMHISPANIA SA
Active
11525
N/A
1995-05-19
II
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FARMHISPANIA SA
Active
34295
Complete
2020-07-28
2019-12-23
2019-12-20
II
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