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

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01 ANHYDROUS DOCETAXEL (1)

02 APREMILAST (AMORPHOUS) (1)

03 AZACITIDINE (1)

04 BENDAMUSTINE HYDROCHLORIDE (1)

05 CABAZITAXEL (AMORPHOUS) (1)

06 CAPECITABINE USP (1)

07 CAPECITABINE USP (PROCESS II) (1)

08 CARFILZOMIB (1)

09 CARMUSTINE USP (1)

10 DABIGATRAN ETEXILATE MESYLATE FORM-I (1)

11 DALFAMPRIDINE (1)

12 DASATINIB (1)

13 DECITABINE (1)

14 DIMETHYL FUMARATE (1)

15 DIROXIMEL FUMARATE (1)

16 DOCETAXEL ANHYDROUS USP (1)

17 DOCETAXEL ANHYDROUS USP (PROCESS II) (1)

18 DOCETAXEL TRIHYDRATE API (1)

19 DOFETILIDE USP (1)

20 DOXORUBICIN HYDROCHLORIDE USP (1)

21 ERLOTINIB HYDROCHLORIDE (1)

22 FESOTERODINE FUMARATE (1)

23 FINGOLIMOD HYDROCHLORIDE (FORM 1) (1)

24 GEMCITABINE HYDROCHLORIDE USP (1)

25 GEMCITABINE HYDROCHLORIDE USP (PROCESS-III) (1)

26 IMATINIB MESYLATE (ß-FORM) (1)

27 LACOSAMIDE (1)

28 LURASIDONE HYDROCHLORIDE (1)

29 PACLITAXEL (SEMI SYNTHETIC) USP (PROCESS-II) (1)

30 PACLITAXEL API (1)

31 PACLITAXEL USP (SEMI-SYNTHETIC) (1)

32 PAZOPANIB HYDROCHLORIDE (1)

33 PERAMPANEL (1)

34 PRASUGREL HYDROCHLORIDE (1)

35 PREGABALIN (1)

36 PREGABALIN USP (PROCESS-II) (1)

37 RIBOCICLIB SUCCINATE (1)

38 RIVAROXABAN FORM- I (MICRONIZED) (1)

39 SODIUM THIOSULFATE (1)

40 TERIFLUNOMIDE (1)

41 TIPIRACIL HYDROCHLORIDE (1)

42 TOFACITINIB CITRATE (1)

43 TRAZODONE HYDROCHLORIDE USP (1)

44 TRIFLURIDINE USP (1)

45 VILAZODONE HYDROCHLORIDE (AMORPHOUS) (1)

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01 ACCORD HEALTHCARE INC (3)

02 INTAS PHARMACEUTICALS LTD (42)

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01 India (42)

02 United Kingdom (3)

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01 Active (38)

02 Inactive (7)

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01 Complete (34)

02 Blank (11)

URL Supplier Web Content
ACCORD HEALTHCARE INC
Inactive
20608
N/A
2007-06-11
II
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INTAS PHARMACEUTICALS...
Inactive
32179
N/A
2017-10-23
II
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INTAS PHARMACEUTICALS...
Active
27821
Complete
2014-02-20
2013-12-27
2013-12-30
II
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INTAS PHARMACEUTICALS...
Active
38685
Complete
2023-10-05
2023-08-11
2023-08-31
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INTAS PHARMACEUTICALS...
Active
27978
Complete
2014-03-28
2014-02-19
2014-02-20
II
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INTAS PHARMACEUTICALS...
Active
24370
N/A
2010-11-09
II
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INTAS PHARMACEUTICALS...
Active
33574
Complete
2019-04-12
2019-02-14
2019-03-04
II
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INTAS PHARMACEUTICALS...
Active
35083
Complete
2020-10-09
2020-09-01
2020-09-08
II
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INTAS PHARMACEUTICALS...
Active
33730
Complete
2019-04-12
2019-03-22
2019-03-26
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INTAS PHARMACEUTICALS...
Inactive
28475
N/A
2014-07-25
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