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

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01 ABIRATERONE ACETATE (1)

02 ANAGRELIDE HYDROCHLORIDE MONOHYDRATE (1)

03 ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE (1)

04 ARSENIC TRIOXIDE (1)

05 AZACITIDINE (1)

06 BOSENTAN, NON-STERILE BULK DRUG SUBSTANCE (1)

07 BROENAC SODIUM (SESQUIHYDRATE) (1)

08 CLEVIDIPINE (1)

09 CLOCORTOLONE PIVALATE (1)

10 DEXMEDETOMIDINE HCL (1)

11 DIFLUPREDNATE (1)

12 DOBUTAMINE HYDROCHLORIDE (1)

13 DOFETILIDE USP (1)

14 DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG (1)

15 ELTROMBOPAG OLAMINE (1)

16 EPINASTINE HCL (1)

17 ESMOLOL HCL (1)

18 ETHACRYNATE SODIUM NON-STERILE, BULK DRUG (1)

19 ETHACRYNIC ACID USP NON-STERILE BULK DRUG (1)

20 ETOMIDATE USP NON STERILE BULK DRUG SUBSTANCE (1)

21 FENOLDOPAM MESYLATE (NON-STERILE BULK DRUG SUBSTANCE) (1)

22 FOMEPIZOLE (1)

23 FOSCARNET SODIUM USP (1)

24 FOSPHENYTOIN SODIUM USP (1)

25 INAMRINONE USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE (1)

26 ISOPROTERENOL HCL USP (1)

27 LAPATINIB DITOSYLATE MONOHYDRATE (1)

28 MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE (1)

29 MELPHALON USP (1)

30 METHYLENE BLUE USP (1)

31 MIDOSTAURIN (1)

32 MILRINONE, NON-STERILE BULK DRUG (1)

33 MITOMYCIN (1)

34 NELARABINE (1)

35 NEPAFENAC, NON-STERILE BULK DRUG SUBSTANCE (1)

36 NEPAFENAC, STERILE BULK DRUG SUBSTANCE (1)

37 NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE (1)

38 PAMIDRONIC ACID (1)

39 PEMETREXED DISODIUM (1)

40 PENCICLOVIR (1)

41 ROPIVACAINE HCL MONOHYDRATE (1)

42 SELENIOUS ACID USP (1)

43 SODIUM NITROPRUSSIDE (1)

44 SODIUM TETRADECYL SULFATE (STDS)(NON-STERILE BULK DRUG SUBSTANCE) (1)

45 SPINOSAD (1)

46 TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE) (1)

47 TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE) (1)

48 TIAGABINE HYDROCHLORIDE (1)

49 TOPOTECAN HCL (1)

50 TRIENTINE HYDROCHLORIDE USP (1)

51 ZIPRASIDONE MESILATE TRIHYDRATE (1)

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01 CHEM WERTH INC (1)

02 CHEMWERTH INC (50)

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01 U.S.A (51)

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01 Active (51)

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01 Complete (34)

02 Blank (17)

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