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

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01 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GIFU PREF, JAPAN (1)

02 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KAMINO, JAPAN. (1)

03 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MUKAIMACHI, JAPAN. (1)

04 PHENYLPROPANOLAMINE HYDROCHLORIDE (1)

05 PROTAMINE SULFATE (1)

06 SENNOSIDES USP (1)

07 SENNOSIDES(60) (1)

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01 ALPS PHARMACEUTICAL IND CO LTD (7)

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01 Japan (7)

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01 Active (1)

02 Inactive (6)

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01 Complete (1)

02 Blank (6)

URL Supplier Web Content
ALPS PHARMACEUTICAL I...
Inactive
4255
N/A
1981-07-08
II
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ALPS PHARMACEUTICAL I...
Active
20538
Complete
2018-10-18
2018-09-27
2007-05-11
II
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ALPS PHARMACEUTICAL I...
Inactive
13991
N/A
1999-02-23
II
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URL Supplier Web Content
ALPS PHARMACEUTICAL I...
Inactive
14132
N/A
1999-05-01
II
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MANUFACTURING SITE, FACILITIES, PER...

URL Supplier Web Content
ALPS PHARMACEUTICAL I...
Inactive
13990
N/A
1999-02-23
II
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MANUFACTURING SITE, FACILITIES, PER...

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ALPS PHARMACEUTICAL I...
Inactive
9325
N/A
1991-09-03
II
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MANUFACTURING SITE, FACILITIES, PER...

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ALPS PHARMACEUTICAL I...
Inactive
9326
N/A
1991-09-03
II
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