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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Qilu Antibiotics Pharmaceutical Co., Ltd. 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 AFATINIB DIMALEATE (1)

04 AZACITIDINE (1)

05 CEFEPIME FOR INJECTION (1)

06 CEFIXIME (1)

07 CEFPODOXIME PROXETIL (1)

08 CEFPROZIL (1)

09 CEFTAZIDIME FOR INJECTION (1)

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

11 ERLOTINIB HYDROCHLORIDE (1)

12 ERTAPENEM SODIUM (1)

13 GEFITINIB (1)

14 MEROPENEM WITH SODIUM CARBONATE (1)

15 PACA INTERMEDIATE (1)

16 PALBOCICLIB (1)

17 STERILE AVIBACTAM SODIUM (1)

18 STERILE CEFAZOLIN SODIUM (1)

19 STERILE CEFAZOLIN SODIUM BULK ANTIBIOTIC DRUG SUBSTANCE (1)

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

21 STERILE CEFOPERAZONE SODIUM (1)

22 STERILE CEFOTAXIME SODIUM (1)

23 STERILE CEFTAROLINE FOSAMIL WITH ARGININE (1)

24 STERILE CEFTRIAXONE SODIUM (1)

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

26 TENOFOVIR DISOPROXIL FUMARATE (1)

27 TERBINAFINE HYDROCHLORIDE (NON STERILE, API) (1)

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

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01 QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTD (2)

02 QILU ANTIBIOTICS PHARMACEUTICAL CO LTD (17)

03 SHANDONG ANHONG PHARMACEUTICAL CO LTD (9)

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01 China (28)

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01 Active (21)

02 Inactive (7)

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01 Complete (19)

02 Blank (9)

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QILU ANTIBIOTICS PHAR...
Inactive
21787
N/A
2008-06-18
II
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SHANDONG ANHONG PHARM...
Active
32637
Complete
2018-04-25
2018-04-03
2018-02-24
II
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SHANDONG ANHONG PHARM...
Active
33080
Complete
2019-03-21
2019-02-12
2019-02-11
II
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SHANDONG ANHONG PHARM...
Active
29771
Complete
2015-12-18
2015-09-24
2015-09-25
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QILU ANTIBIOTICS PHAR...
Active
25303
Complete
2013-08-17
2013-08-07
2011-09-15
II
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QILU ANTIBIOTICS PHAR...
Active
36694
Complete
2022-11-28
2022-08-19
2022-07-22
II
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QILU ANTIBIOTICS PHAR...
Active
34502
Complete
2020-03-09
2020-01-21
2020-02-17
II
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QILU ANTIBIOTICS PHAR...
Active
26699
Complete
2015-07-10
2012-12-19
2013-01-09
II
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QILU ANTIBIOTICS PHAR...
Active
20481
Complete
2018-12-10
2013-09-06
2006-12-28
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QILU ANTIBIOTICS PHAR...
Inactive
19521
N/A
2006-06-01
II
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