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

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01 ANASTROZOLE (1)

02 ANASTROZOLE USP (1)

03 AXITINIB (1)

04 AZACITIDINE (1)

05 BENDAMUSTINE HCL (1)

06 BICALUTAMIDE USP (1)

07 BORTEZOMIB (2)

08 BUSULFAN USP (1)

09 CABAZITAXEL (1)

10 CAPECITABINE USP (1)

11 CLOFARABINE (1)

12 CYCLOPHOSPHAMIDE USP (1)

13 DECITABINE (1)

14 DIMETHYL FUMARATE (1)

15 ENZALUTAMIDE (1)

16 ERLOTINIB HYDROCHLORIDE (ET) (1)

17 FINGOLIMOD HYDROCHLORIDE (1)

18 GEMCITABINE HYDROCHLORIDE USP (1)

19 GEMCITABINE HYDROCHLORIDE USP (PROCESS -2) (1)

20 IBRUTINIB (1)

21 IMATINIB MESYLATE (1)

22 IMATINIB MESYLATE (IMN) (1)

23 IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP (1)

24 LENALIDOMIDE (1)

25 LENVATINIB MESYLATE (1)

26 LETROZOLE USP (1)

27 MELPHALAN HYDROCHLORIDE (MPH) (1)

28 NIFEDIPINE-USP (1)

29 NILOTINIB (1)

30 OXALIPLATIN USP (1)

31 PEMETREXED DIPOTASSIUM (NONA HYDRATE) (PMN) (1)

32 PEMETREXED DISODIUM (HEMIPENTA HYDRATE) (1)

33 PHENYLEPHRINE HYDROCHLORIDE, USP (1)

34 PIRFENIDONE (1)

35 POMALIDOMIDE (1)

36 PRUCALOPRIDE SUCCINATE (1)

37 SUNITINIB (1)

38 SUNITINIB MALATE (1)

39 TEMOZOLOMIDE USP (1)

40 TENOFOVIR ALAFENAMIDE FUMARATE (1)

41 TERIFLUNOMIDE (1)

42 THALIDOMIDE USP (1)

43 TRANEXAMIC ACID USP (1)

44 VARENICLINE TARTRATE (1)

45 ZOLEDRONIC ACID (1)

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01 SHILPA MEDICARE LTD (2)

02 SHILPA PHARMA LIFESCIENCES LTD (44)

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01 India (46)

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01 Active (45)

02 Inactive (1)

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01 Complete (44)

02 Blank (2)

URL Supplier Web Content
SHILPA MEDICARE LTD
Inactive
23123
N/A
2009-09-23
II
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SHILPA PHARMA LIFESCI...
Active
29654
Complete
2015-12-15
2015-09-23
2015-09-18
II
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SHILPA PHARMA LIFESCI...
Active
30104
Complete
2016-02-05
2015-12-23
2015-12-24
II
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SHILPA PHARMA LIFESCI...
Active
27487
Complete
2014-03-15
2013-09-23
2013-09-23
II
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SHILPA PHARMA LIFESCI...
Active
25222
Complete
2013-06-20
2012-12-19
2011-11-08
II
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SHILPA PHARMA LIFESCI...
Active
24690
Complete
2014-04-04
2013-09-23
2011-05-11
II
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SHILPA PHARMA LIFESCI...
Active
24944
Complete
2014-01-31
2013-02-13
2011-08-23
II
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SHILPA PHARMA LIFESCI...
Active
36821
Complete
2022-05-25
2022-05-20
2022-03-09
II
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SHILPA PHARMA LIFESCI...
Active
25491
Complete
2013-07-02
2012-12-19
2011-12-07
II
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SHILPA PHARMA LIFESCI...
Active
33087
Complete
2020-07-28
2020-07-02
2020-06-30
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