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

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01 APIXABAN (1)

02 BUDESONIDE MICRONIZED (1)

03 ESLICARBAZEPINE ACETATE (1)

04 ESMOLOL HYDROCHLORIDE (1)

05 ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZED (1)

06 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (1)

07 FLUORESCEIN (1)

08 LAPATINIB DITOSYLATE (1)

09 METHAZOLAMIDE (1)

10 MIRABEGRON (1)

11 MONTELUKAST SODIUM THIOL ACID (1)

12 PENTAMIDINE ISETHIONATE (1)

13 PYRAZINAMIDE (1)

14 ROSUVASTATIN CALCIUM (1)

15 SOLIFENACIN SUCCINATE (1)

16 SORAFENIB HEMITOSYLATE (1)

17 SUCCINYLCHOLINE CHLORIDE (1)

18 TOFACITINIB CITRATE (1)

19 VINBLASTINE SULFATE (1)

20 VINCRISTINE SULFATE (1)

21 VINORELBINE TARTRATE (1)

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01 DELMAR CHEMICALS INC (15)

02 MINAKEM (3)

03 MINAKEM HIGH POTENT (3)

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01 Canada (15)

02 France (6)

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01 Active (21)

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01 Complete (15)

02 Blank (6)

DELMAR CHEMICALS INC
Active
30336
Complete
2016-08-15
2016-03-28
2016-03-14
II
Minakem Delmar

Cophex 2024

Not Confirmed

envelop Contact Supplier
DELMAR CHEMICALS INC
Active
31791
Complete
2018-07-27
2017-06-09
2017-06-05
II
Minakem Delmar

Cophex 2024

Not Confirmed

envelop Contact Supplier
DELMAR CHEMICALS INC
Active
4475
Complete
2020-05-21
2020-05-15
1982-03-12
II
Minakem Delmar

Cophex 2024

Not Confirmed

envelop Contact Supplier
DELMAR CHEMICALS INC
Active
18791
N/A
2005-09-16
II
Minakem Delmar

Cophex 2024

Not Confirmed

envelop Contact Supplier
DELMAR CHEMICALS INC
Active
32266
Complete
2018-12-03
2018-01-24
2018-01-17
II
Minakem Delmar

Cophex 2024

Not Confirmed

envelop Contact Supplier
DELMAR CHEMICALS INC
Active
8676
N/A
1990-08-01
II
Minakem Delmar

Cophex 2024

Not Confirmed

envelop Contact Supplier
DELMAR CHEMICALS INC
Active
32929
Complete
2020-12-03
2018-07-09
2018-09-14
II
Minakem Delmar

Cophex 2024

Not Confirmed

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