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

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01 7-AMINO CEPHALOSPORANIC ACID (7-ACA) (1)

02 ABIRATERONE ACETATE (NON-STERILE) (1)

03 ADEFOVIR DIPIVOXIL (NON STERILE, API) (1)

04 AFATINIB DIMALEATE (1)

05 ALPRAZOLAM USP (NON STERILE API) (1)

06 AMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT (1)

07 AZACITIDINE (1)

08 BORTEZOMIB (NON-STERILE, API) (1)

09 BUFLOMEDIL HYDROCHLORIDE (NON STERILE API) (1)

10 CABAZITAXEL (1)

11 CAPECITABINE (NON-STERILE API) (2)

12 CARBOPLATIN (NON-STERILE API) (1)

13 CARBOPLATIN USP (1)

14 CARFILZOMIB (NON-STERILE, API) (1)

15 CEFEPIME FOR INJECTION (1)

16 CEFIXIME (1)

17 CEFPODOXIME PROXETIL (1)

18 CEFPROZIL (1)

19 CEFTAZIDIME FOR INJECTION (1)

20 CEFUROXIME SODIUM, STERILE BULK ANTIBIOTIC DRUG SUBSTANCE (1)

21 CISPLATIN (NON STERILE API) (1)

22 CLOFARABINE (1)

23 DECITABINE (1)

24 DOCETAXEL USP (2)

25 ERLOTINIB HYDROCHLORIDE (1)

26 ERTAPENEM SODIUM (1)

27 ETOPOSIDE (NON-STERILE API) (1)

28 EXEMESTANE (NON STERILE API) (1)

29 EXEMESTANE (NON-STERILE, API) (1)

30 FOSAPREPITANT DIMEGLUMINE (NON-STERILE API) (1)

31 GEFITINIB (1)

32 HYDROXYUREA USP (NON-STERILE BULK) (1)

33 IMATINIB MESYLATE (NON-STERILE API) (1)

34 IRINOTECAN HYDROCHLORIDE (NON STERILE, API) (1)

35 MEROPENEM WITH SODIUM CARBONATE (1)

36 NICARDIPINE HYDROCHLORIDE USP (1)

37 OLANZAPINE (1)

38 OLMESARTAN MEDOXOMIL (NON-STERILA API) (1)

39 OLMESARTAN MEDOXOMIL USP (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) (1)

40 ONDANSETRON (1)

41 ONDANSETRON HYDROCHLORIDE (NON-STERILE API) (1)

42 OXALIPLATIN USP (NON-STERILE API) (1)

43 PACA INTERMEDIATE (1)

44 PALBOCICLIB (1)

45 PALIPERIDONE PALMITATE (STERILE) (1)

46 PALONOSETRON HYDROCHLORIDE USP (NON STERILE API) (1)

47 PEMETREXED DISODIUM (1)

48 PIPERACILLIN (NON STERILE BULK FORM) (1)

49 PIPERACILLIN (NON-STERILE API) (1)

50 PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (1)

51 PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (PROCESS IV) (1)

52 PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (STERILE API) (1)

53 PIPERACILLIN USP (NON-STERILE API) (1)

54 RISPERIDONE (NON STERILE, API) (1)

55 RISPERIDONE PROCESS II (NON STERILE, API) (1)

56 ROPIVACAINE HYDROCHLORIDE (NON STERILE, API) (1)

57 SOLIFENACIN SUCCINATE (NON-STERILE, API) (1)

58 SPINOSAD INTERMEDIATE (NON-STERILE, VETERINARY GRADE) (1)

59 STERILE AVIBACTAM SODIUM (1)

60 STERILE CEFAZOLIN SODIUM (1)

61 STERILE CEFAZOLIN SODIUM BULK ANTIBIOTIC DRUG SUBSTANCE (1)

62 STERILE CEFAZOLIN SODIUM PROCESS 1 BULK ANTIBIOTIC DRUG SUBSTANCE (1)

63 STERILE CEFOPERAZONE SODIUM (1)

64 STERILE CEFOTAXIME SODIUM (1)

65 STERILE CEFTAROLINE FOSAMIL WITH ARGININE (1)

66 STERILE CEFTRIAXONE SODIUM (1)

67 STERILE CEFUROXIME SODIUM PROCESS 1, BULK ANTIBIOTIC DRUG SUBSTANCE (1)

68 SULBACTAM SODIUM (NON-STERILE API) (1)

69 TADALAFIL (1)

70 TAZOBACTAM (NON-STERILE API) (1)

71 TAZOBACTAM (TRIAZOLE PROCESS) (1)

72 TAZOBACTAM ACID (INTERMEDIATE, NON-STERILE BULK) (1)

73 TAZOBACTAM ACID (PROCESS I, NON-STERILE BULK) (1)

74 TAZOBACTAM ACID (PROCESS V, NON-STERILE API) (1)

75 TAZOBACTAM SODIUM (STERILE API) (2)

76 TENOFOVIR DISOPROXIL FUMARATE (1)

77 TERBINAFINE HYDROCHLORIDE (NON STERILE, API) (2)

78 TOFACITINIB CITRATE (NON-STERILE API) (1)

79 VINORELBINE TARTRATE (PROCESS I) (NON STERILE, API) (1)

80 WARFARIN SODIUM (NON-STERILE, API) (1)

81 ZIPRASIDONE HYDROCHLORIDE (NON - STERILE API) (1)

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01 QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTD (2)

02 QILU ANTIBIOTICS PHARMACEUTICAL CO LTD (17)

03 QILU PHARMACEUTICAL CO LTD (27)

04 QILU PHARMACEUTICAL HULUN BUIR BRANCH (1)

05 QILU TIANHE PHARMACEUTICAL CO LTD (7)

06 SHANDONG ANHONG PHARMACEUTICAL CO LTD (13)

07 SHANDONG ANXIN PHARMACEUTICAL CO LTD (18)

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01 China (85)

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01 Active (57)

02 Inactive (28)

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01 Complete (51)

02 Blank (34)

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QILU ANTIBIOTICS PHAR...
Inactive
21787
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2008-06-18
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SHANDONG ANHONG PHARM...
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32637
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2018-04-25
2018-04-03
2018-02-24
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QILU PHARMACEUTICAL C...
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25641
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2011-12-28
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SHANDONG ANHONG PHARM...
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33080
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2019-03-21
2019-02-12
2019-02-11
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QILU TIANHE PHARMACEU...
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22036
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2008-09-23
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SHANDONG ANXIN PHARMA...
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20874
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2013-11-25
2013-11-18
2007-09-18
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SHANDONG ANHONG PHARM...
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29771
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2015-12-18
2015-09-24
2015-09-25
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QILU PHARMACEUTICAL C...
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29308
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2016-04-06
2015-05-21
2015-05-06
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QILU TIANHE PHARMACEU...
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22039
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2008-09-28
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SHANDONG ANHONG PHARM...
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27441
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2014-02-08
2013-09-06
2013-09-26
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