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

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01 (R)-4-PROPYLDIHYDROFURAN-2(3H)-ONE (BRIVARACETAM INTERMEDIATE) (1)

02 ALOGLIPTIN BENZOATE NON-STERILE BULK DRUG SUBSTANCE (1)

03 APIXABAN NON-STERILE BULK DRUG SUBSTANCE (1)

04 APREMILAST NON-STERILE BULK DRUG SUBSTANCE (1)

05 ARIPIPRAZOLE NON-STERILE BULK DRUG SUBSTANCE (1)

06 ATORVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE (1)

07 AZILSARTAN KAMEDOXOMIL NON-STERILE BULK DRUG SUBSTANCE (1)

08 AZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM (1)

09 AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE (1)

10 AZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE (1)

11 BESIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE (1)

12 BRIVARACETAM NON-STERILE BULK DRUG SUBSTANCE (1)

13 CLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM (1)

14 CLOPIDOGREL BISULFATE NON-STERILE BULK DRUG SUBSTANCE (1)

15 DULOXETINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE (1)

16 ENTACAPONE NON-STERILE BULK DRUG SUBSTANCE (1)

17 ERYTHROMYCIN THIOCYANATE, PHARMACEUTICAL INTERMEDIATE BULK FORM (1)

18 ERYTHROMYCIN USP, NON-STERILE BULK FORM (1)

19 ESCITALOPRAM OXALATE NON-STERILE BULK DRUG SUBSTANCE (1)

20 ESCITALOPRAM OXALATE NON-STERILE BULK SUBSTANCE (1)

21 ESOMEPRAZOLE MAGNESIUM DIHYDRATE NON-STERILE BULK DRUG SUBSTANCE (1)

22 FEBUXOSTAT NON-STERILE BULK DRUG SUBSTANCE (1)

23 FELODIPINE NON-STERILE BULK DRUG SUBSTANCE (1)

24 FINGOLIMOD HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE (1)

25 IRBESARTAN NON-STERILE BULK DRUG SUBSTANCE (1)

26 LEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE (1)

27 LINAGLIPTIN, NON-STERILE BULK DRUG SUBSTANCE (1)

28 LINCOMYCIN HYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE, BULK FORM (1)

29 METOPROLOL SUCCINATE NON-STERILE BULK DRUG SUBSTANCE (1)

30 METRONIDAZOLE USP, NON-STERILE BULK FORM (1)

31 MOXIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE (1)

32 OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE (1)

33 OLMESARTAN MEDOXOMIL NON-STERILE BULK DRUG SUSTANCE (1)

34 OSELTAMIVIR PHOSPHATE NON-STERILE BULK DRUG SUBSTANCE (1)

35 PRASUGREL HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE (1)

36 RITONAVIR NON-STERILE BULK DRUG SUBSTANCE (1)

37 RIVAROXABAN, NON-STERILE BULK DRUG SUBSTANCE (1)

38 ROSUVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE (1)

39 Rosuvastatin intermediate RSV01 (1)

40 SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE (1)

41 SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM (1)

42 SITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE (1)

43 SOLIFENACIN SUCCINATE NON-STERILE BULK DRUG SUBSTANCE (1)

44 SUGAMMADEX SODIUM NON STERILE BULK DRUG SUBSTANCE (1)

45 TADALAFIL NON-STERILE BULK DRUG SUBSTANCE (1)

46 TENOFOVIR ALAFENAMIDE FUMARATE NON-STERILE BULK DRUG SUBSTANCE (1)

47 TICAGRELOR NON-STERILE BULK DRUG SUBSTANCE (1)

48 ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM (1)

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01 HEC PHARM CO (1)

02 HEC PHARM CO LTD (24)

03 HEC PHARM USA INC (2)

04 RUYUAN HEC PHARM CO LTD (21)

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01 China (48)

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01 Active (40)

02 Inactive (8)

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01 Complete (30)

02 Blank (18)

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2020-12-01
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RUYUAN HEC PHARM CO L...
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30913
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2016-12-20
2016-09-13
2016-09-30
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RUYUAN HEC PHARM CO L...
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2016-11-22
2016-09-12
2016-08-31
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RUYUAN HEC PHARM CO L...
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34088
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2019-08-31
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RUYUAN HEC PHARM CO L...
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30954
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2016-11-22
2016-09-23
2016-09-28
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HEC PHARM CO LTD
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27664
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2013-10-25
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HEC PHARM CO LTD
Active
28452
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2014-10-27
2014-08-26
2014-08-14
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HEC PHARM CO LTD
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28837
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2015-06-09
2014-12-30
2014-10-31
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HEC PHARM CO LTD
Inactive
20852
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2007-09-10
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RUYUAN HEC PHARM CO L...
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28453
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2015-06-16
2015-03-13
2014-10-23
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