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List of Drug Master Files (DMF) of Protamine Sulfate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ALPS Pharmaceutical Ind. Co. Ltd. (1)

02 Amphastar Pharmaceuticals (1)

03 Biochem Corporation JP 350-0814 Saitama (1)

04 GLAND PHARMA LIMITED (1)

05 Reliable Biopharmaceutical Corporation (1)

06 Yuki Gosei Kogyo Co., Ltd. (2)

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01 PROTAMINE SULFATE (5)

02 PROTAMINE SULFATE USP (2)

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01 India (1)

02 Japan (4)

03 U.S.A (2)

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01 Active (4)

02 Inactive (3)

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01 Complete (4)

02 Blank (3)

URL Supplier Web Content
20538
Active
2007-05-11
Complete
2018-10-18
2018-09-27
II
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URL Supplier Web Content
30429
Active
2016-09-16
Complete
2022-10-19
2022-10-11
II
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URL Supplier Web Content
14973
Inactive
2000-07-27
N/A
II
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URL Supplier Web Content
36568
Active
2021-12-29
Complete
2022-03-23
2021-12-14
II
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URL Supplier Web Content
19008
Inactive
2005-12-02
N/A
II
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URL Supplier Web Content
15421
Active
2000-01-25
Complete
2012-11-11
2012-11-28
II
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URL Supplier Web Content
4626
Inactive
1982-07-30
N/A
II
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