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

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01 ALPRAZOLAM USP (NON STERILE API) (1)

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

03 BUFLOMEDIL HYDROCHLORIDE (NON STERILE API) (1)

04 CAPECITABINE (NON-STERILE API) (2)

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

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

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

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

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

10 PIPERACILLIN (NON-STERILE API) (1)

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

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

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

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

15 TADALAFIL (1)

16 TAZOBACTAM (NON-STERILE API) (1)

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

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

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

20 TAZOBACTAM SODIUM (STERILE API) (1)

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

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

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01 QILU TIANHE PHARMACEUTICAL CO LTD (7)

02 SHANDONG ANXIN PHARMACEUTICAL CO LTD (16)

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01 China (23)

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01 Active (16)

02 Inactive (7)

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01 Complete (16)

02 Blank (7)

URL Supplier Web Content
QILU TIANHE PHARMACEU...
Inactive
22036
N/A
2008-09-23
II
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SHANDONG ANXIN PHARMA...
Active
20874
Complete
2013-11-25
2013-11-18
2007-09-18
II
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QILU TIANHE PHARMACEU...
Inactive
22039
N/A
2008-09-28
II
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QILU TIANHE PHARMACEU...
Inactive
24529
N/A
2010-12-31
II
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SHANDONG ANXIN PHARMA...
Active
27085
Complete
2016-04-06
2015-08-19
2013-04-02
II
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SHANDONG ANXIN PHARMA...
Active
33142
Complete
2019-01-29
2018-11-27
2018-11-30
II
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SHANDONG ANXIN PHARMA...
Active
20615
Complete
2013-05-13
2012-12-13
2007-06-15
II
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SHANDONG ANXIN PHARMA...
Active
29656
Complete
2016-08-03
2015-09-29
2015-08-27
II
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QILU TIANHE PHARMACEU...
Inactive
26420
N/A
2012-09-06
II
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SHANDONG ANXIN PHARMA...
Active
29640
Complete
2016-02-10
2015-09-29
2015-08-21
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