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Athena Athena

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

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01 BULK PRODUCTION OF OXENDOLONE IN THE HIKARI PLANT (1)

02 CEFSULODIN SODIUM (SCE-129) (1)

03 EM574 (1)

04 ESTAZOLAM (TA-8) (1)

05 FACILITIES AND OPERATING PROCEDURES IN HIKARI-CITY, YAMAGUCHI, JAPAN (1)

06 FOLIC ACID (1)

07 HYDROMORPHONE HYDROCHLORIDE (1)

08 LEUPROLIDE ACETATE (1)

09 LORNOXICAM (1)

10 LUPRON DEPOT AND LUPRON DEPOT VEHICLE (1)

11 MANUF OF CEFMENOXIME HCL IN THE HIKARI PLANT (1)

12 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHONAN PLANT. (1)

13 MIDODRINE HYDROCHLORIDE (1)

14 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

15 PHARMACEUTICAL PROCESSING OF CEFMENOXINE HCL FOR INJECT -HIKARI PLANT (1)

16 PODOPHYLLOTOXIN (1)

17 PROCESSING OF OXENDOLONE AQUOSUSPENSOID INJ IN THE OSAKA PLANT (1)

18 PYRIDOXINE HYDROCHLORIDE (2)

19 RIDAFOROLIMUS DRUG SUBSTANCE (1)

20 SODIUM DEACETYL CEPHALOSPORIN C (DCPE-Na) PRODUCTION IN HIKARI PLANT (1)

21 STERILE ANHYDROUS SODIUM CARBONATE (1)

22 STERILE CEFOTIAM (2)

23 SUXAMETHONIUM CHLORIDE (1)

24 TAK-536 DRUG SUBSTANCE (1)

25 TAK-603 (1)

26 TAP-144 LEUPROLIDE BULK PRODUCTION IN CENTRAL RESEARCH DIVISION (1)

27 TAP-144-SR (1M) (1)

28 TAP-144-SR (3M) (22.5MG.) (1)

29 TAP-144-SR INJECTION (EXTENDED-RELEASE FORM OF LEUPROLIDE ACETATE) (1)

30 TAP-144-SR(N) 7.5 AND 3.75 MG. (1)

31 TNP-470 (1)

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01 MEDINOL LTD (1)

02 NYCOMED AUSTRIA GMBH (4)

03 TAKEDA CHEMICAL INDUSTRIES LTD (21)

04 TAKEDA GMBH (1)

05 TAKEDA PHARMACEUTICAL CO LTD (6)

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01 Austria (3)

02 Japan (28)

03 Switzerland (1)

04 U.S.A (1)

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01 Active (4)

02 Inactive (29)

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01 Blank (33)

URL Supplier Web Content
TAKEDA CHEMICAL INDUS...
Inactive
5609
N/A
1984-10-24
II
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TAKEDA CHEMICAL INDUS...
Inactive
3414
N/A
1979-01-23
II
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TAKEDA CHEMICAL INDUS...
Inactive
2859
N/A
1977-02-10
II
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TAKEDA PHARMACEUTICAL...
Inactive
2318
N/A
1974-08-23
II
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TAKEDA PHARMACEUTICAL...
Inactive
7071
N/A
1987-07-13
II
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TAKEDA PHARMACEUTICAL...
Active
10416
N/A
1993-08-13
II
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NYCOMED AUSTRIA GMBH
Inactive
16755
N/A
2003-08-07
II
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TAKEDA PHARMACEUTICAL...
Inactive
7021
N/A
1987-06-09
II
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TAKEDA CHEMICAL INDUS...
Inactive
4616
N/A
1982-07-12
II
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NYCOMED AUSTRIA GMBH
Inactive
6315
N/A
1986-03-10
II
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