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

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01 AMOXYCILLIN TRIHYDRATE (1)

02 AMPICILLIN TRIHYDRATE (1)

03 ATENOLOL (1)

04 ATENOLOL USP (1)

05 AZITHROMYCIN DIHYDRATE USP (1)

06 BIAPENEM STERILE (1)

07 CLOXACILLIN SODIUM (1)

08 DORIPENEM STERILE (1)

09 FACILITIES AND OPERATIONS IN MAHARASHTRA, INDIA (1)

10 METOPROLOL SUCCINATE (1)

11 METOPROLOL TARTRATE USP (1)

12 PREGABALIN (1)

13 PREGBALIN USP (1)

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01 KOPRAN LTD (6)

02 KOPRAN RESEARCH LABORATORIES LTD (7)

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01 India (13)

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01 Active (5)

02 Inactive (8)

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01 Complete (1)

02 Blank (12)

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KOPRAN LTD
Inactive
8845
N/A
1990-11-15
II
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KOPRAN LTD
Inactive
8843
N/A
1990-11-15
II
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KOPRAN LTD
Inactive
25010
N/A
2011-05-20
II
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KOPRAN RESEARCH LABOR...
Active
33007
Complete
2019-01-17
2018-09-06
2018-07-27
II
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KOPRAN RESEARCH LABOR...
Active
34853
N/A
2020-05-21
II
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KOPRAN RESEARCH LABOR...
Inactive
34914
N/A
2020-06-16
II
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KOPRAN LTD
Inactive
8844
N/A
1990-11-15
II
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KOPRAN RESEARCH LABOR...
Inactive
34913
N/A
2020-06-16
II
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KOPRAN RESEARCH LABOR...
Active
35110
N/A
2020-08-20
II
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KOPRAN RESEARCH LABOR...
Active
34903
N/A
2020-05-30
II
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