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Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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

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01 5-BROMO-2' -DEOXYURIDINE (BDU)-PRODUCT NO. 6706 (1)

02 5-FLUORO-URACIL,PRODUCT 4965 (1)

03 ADENINE AND ADENINE HCL (SYNTHETIC & FROM RNA OR ADENOSINE) (1)

04 ADENOSINE (1)

05 ADENOSINE-5-MONOPHOSPHORIC ACID, PRODUCT #2030 (1)

06 FLUCYTOSINE USP (1)

07 GLUTATHIONE REDUCED (GSH) (1)

08 GLUTATHIONE, OXIDIZED HYDRATE (1)

09 LEVOCARNITINE USP (1)

10 N6-(2-ISOPENTENYL)-ADENOSINE (1)

11 OXYPHENBUTAZONR BULK (1)

12 THYMIDINE (1)

13 URIDINE PRODUCT #3401 (1)

14 URIDINE-5'-TRIPHOSPHATE (UTP), THERAPEUTIC GRADE (1)

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01 ACETO CHEMICAL CO INC (1)

02 ACETO CORP (2)

03 PHARMA-WALDHOF GMBH (11)

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01 Germany (11)

02 Switzerland (1)

03 U.S.A (2)

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01 Active (2)

02 Inactive (12)

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01 Complete (1)

02 Blank (13)

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PHARMA-WALDHOF GMBH
Inactive
3750
N/A
1980-02-28
II
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PHARMA-WALDHOF GMBH
Inactive
4959
N/A
1983-05-18
II
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PHARMA-WALDHOF GMBH
Inactive
3412
N/A
1978-12-20
II
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PHARMA-WALDHOF GMBH
Active
7728
Complete
2013-06-08
2013-05-30
1988-10-25
II
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PHARMA-WALDHOF GMBH
Inactive
4573
N/A
1982-05-04
II
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ACETO CORP
Inactive
15476
N/A
2001-06-07
II
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PHARMA-WALDHOF GMBH
Inactive
3068
N/A
1977-11-09
II
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PHARMA-WALDHOF GMBH
Inactive
2562
N/A
1975-11-13
II
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ACETO CORP
Active
16150
N/A
2002-09-24
II
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PHARMA-WALDHOF GMBH
Inactive
8713
N/A
1990-08-17
II
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