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

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01 APIXABAN (1)

02 BUPROPION HYDROBROMIDE (FORM II) (1)

03 BUPROPION HYDROBROMIDE (FORM-I) (1)

04 BUPROPION HYDROCHLORIDE USP (1)

05 BUPROPION HYDROCHLORIDE USP [PROCESS-2] (1)

06 BUTORPHANOL TARTRATE USP (1)

07 CELECOXIB (1)

08 DABIGATRAN ETEXILATE MESYLATE (1)

09 DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) (1)

10 DESVENLAFAXINE SUCCINATE USP (1)

11 DONEPEZIL HYDROCHLORIDE API (1)

12 EMPAGLIFLOZIN (1)

13 ERTUGLIFLOZIN L-PYROGLUTAMIC ACID (1)

14 FAVIPIRAVIR (1)

15 GABAPENTIN USP (1)

16 GABEPENTIN (A01804) (1)

17 GEIBROZIL API (1)

18 LACOSAMIDE USP (1)

19 LEVETIRACETAM API (1)

20 MEMANTINE HYDROCHLORIDE USP (1)

21 OLMESARTAN MEDOXOMIL USP (1)

22 ONDANSETRON HYDROCHLORIDE USP (1)

23 ONDANSETRON USP (1)

24 PENTOXIFYLLINE USP (1)

25 PREGABALIN (PROCESS-II) (1)

26 PREGABALIN USP (1)

27 QUETIAPINE FUMARATE (PROCESS-B) USP (1)

28 RIVAROXABAN USP (1)

29 SITAGLIPTIN HYDROCHLORIDE (PROCESS B) (1)

30 SITAGLIPTIN PHOSPHATE ANHYDRATE (1)

31 SITAGLIPTIN PHOSPHATE MONOHYDRATE (PROCESS-B) (1)

32 TRIPROLIDINE HYDROCHLORIDE USP (1)

33 VALACYCLOVIR HYDROCHLORIDE USP (1)

34 VENLAFAXINE BASE (1)

35 VENLAFAXINE HYDROCHLORIDE USP (1)

36 VILDAGLIPTIN (1)

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01 HIKAL LTD (36)

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01 India (36)

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01 Active (31)

02 Inactive (5)

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01 Complete (13)

02 Blank (23)

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HIKAL LTD
Active
32364
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2017-12-29
II
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HIKAL LTD
Active
38384
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2023-05-29
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HIKAL LTD
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38231
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2023-03-24
II
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HIKAL LTD
Active
16476
Complete
2014-02-07
2014-01-31
2003-03-13
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HIKAL LTD
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28421
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2014-06-21
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HIKAL LTD
Active
31875
Complete
2022-04-26
2022-04-18
2017-06-29
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HIKAL LTD
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31971
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2017-07-29
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HIKAL LTD
Inactive
31613
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2017-03-25
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HIKAL LTD
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32571
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2018-04-30
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HIKAL LTD
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37426
N/A
2022-08-20
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