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

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01 ACEBUTOLOL HYDROCHLORIDE USP (1)

02 ALOSETRON HYDROCHLORIDE (1)

03 ATOVAQUONE USP (1)

04 ATROPINE SULFATE MONOHYDRATE USP (1)

05 BENAZEPRIL HYDROCHLORIDE USP (1)

06 BETAINE ANHYDROUS (1)

07 CARGLUMIC ACID (1)

08 CEVIMELINE HYDROCHLORIDE USP (1)

09 CHLORZOXAZONE USP (1)

10 DAPSONE USP (1)

11 DIAZOXIDE USP (1)

12 DICHLORPHENAMIDE USP (1)

13 ESTAZOLAM USP (1)

14 FERRIC CITRATE (1)

15 FLUDROCORTISONE ACETATE USP (1)

16 GLYCEROL PHENYLBUTYRATE (1)

17 KETOCONAZOLE USP (1)

18 L-GLUTAMINE USP (1)

19 LEVOCARNITINE USP (1)

20 LEVOKETOCONAZOLE (1)

21 LEVORPHANOL TARTRATE USP (1)

22 METHSUXIMIDE USP (1)

23 Methyltestosterone USP (1)

24 NITISINONE (1)

25 OXANDROLONE USP (1)

26 PHENOXYBENZAMINE HYDROCHLORIDE USP (1)

27 PITOLISANT HYDROCHLORIDE (1)

28 PITOLISANT HYDROCHLORIDE SD (1)

29 PRAZOSIN HYDROCHLORIDE USP (1)

30 PRUCALOPRIDE SUCCINATE (1)

31 RAMELTEON (1)

32 SODIUM PHENYLBUTYRATE USP (1)

33 STIRIPENTOL (1)

34 TAFAMIDIS (1)

35 TAFAMIDIS (CC) (1)

36 TAFAMIDIS MEGLUMINE (1)

37 THIOTHIXENE USP (1)

38 TRANYLCYPROMINE SULFATE USP (1)

39 TREPROSTINIL DIOLAMINE (1)

40 TREPROSTINIL SODIUM (1)

41 TRIENTINE HYDROCHLORIDE USP (1)

42 TRIENTINE TETRAHYDROCHLORIDE (1)

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01 NOVITIUM PHARMA LLC (12)

02 NURAY CHEMICALS PRIVATE LTD (4)

03 NURAY CHEMICALS PVT LTD (2)

04 SS PHARMA LLC (24)

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01 India (19)

02 U.S.A (23)

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01 Active (42)

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01 Complete (40)

02 Blank (2)

SS PHARMA LLC
Active
35857
Complete
2021-06-16
2021-04-30
2021-04-30
II
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Not Confirmed

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NURAY CHEMICALS PVT L...
Active
27378
Complete
2013-10-19
2013-09-12
2013-09-16
II
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Iran Expo

Not Confirmed

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NURAY CHEMICALS PRIVA...
Active
36339
N/A
2021-10-11
II
Nuray Chemicals Company Banner

Iran Expo

Not Confirmed

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SS PHARMA LLC
Active
33781
Complete
2019-09-25
2019-06-25
2019-08-08
II
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Iran Expo

Not Confirmed

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NURAY CHEMICALS PRIVA...
Active
36768
Complete
2022-10-28
2022-02-11
2022-02-07
II
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Iran Expo

Not Confirmed

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NOVITIUM PHARMA LLC
Active
34404
Complete
2020-04-24
2020-03-10
2020-03-12
II
Nuray Chemicals Company Banner

Iran Expo

Not Confirmed

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NOVITIUM PHARMA LLC
Active
33166
Complete
2019-01-11
2018-12-14
2018-12-07
II
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Iran Expo

Not Confirmed

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SS PHARMA LLC
Active
38577
Complete
2023-11-13
2023-09-27
2023-09-28
II
Nuray Chemicals Company Banner

Iran Expo

Not Confirmed

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SS PHARMA LLC
Active
30862
Complete
2016-12-01
2016-09-15
2016-09-12
II
Nuray Chemicals Company Banner

Iran Expo

Not Confirmed

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NOVITIUM PHARMA LLC
Active
27678
Complete
2014-01-16
2013-12-13
2013-12-13
II
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Iran Expo

Not Confirmed

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