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

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01 AMANTADINE HYDROCHLORIDE USP (1)

02 BUPROPION HYDROBROMIDE API (1)

03 BUPROPION HYDROCHLORIDE USP (1)

04 CLOPIDOGREL BISULFATE (1)

05 CLOPIDOGREL BISULFATE (FORM II) (1)

06 DESVENLAFAXINE SUCCINATE (1)

07 DEXTROMETHORPHAN HYDROBROMIDE (1)

08 IRBESARTAN API (1)

09 IRON DEXTRAN (1)

10 LAROPIPRANT (1)

11 LEVALBUTEROL L-TARTRATE (1)

12 LEVETIRACETAM (1)

13 LEVOFLOXACIN HEMIHYDRATE, USP (1)

14 LOVASTATIN USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT (1)

15 METAXALONE (1)

16 METAXALONE API (1)

17 METHOCARBAMOL API (1)

18 METOPROLOL SUCCINATE USP (1)

19 METOPROLOL TARTRATE (1)

20 OXO-ACID DIPA SALT, DRUG SUBSTANCE INTERMEDIATE (1)

21 PREGABALIN (1)

22 PSEUDOEPHEDRINE HYDROCHLORIDE USP (1)

23 QUETIAPINE FUMARATE (1)

24 SIMVASTATIN USP BULK (1)

25 SITAGLIPTIN PHOSPHATE ANHYDROUS (2)

26 TELMISARTAN API (1)

27 TYLOSIN TARTRATE (1)

28 VENLAFAXINE HYDROCHLORIDE (1)

29 VENLAFAXINE HYDROCHLORIDE API (1)

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01 ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD (22)

02 ZHEJIANG APELOA KANGYU BIO PHARMACEUTICAL CO LTD (1)

03 ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD (6)

04 ZHEJIANG APELOA PHARMACEUTICAL CO LTD (1)

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01 China (30)

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01 Active (23)

02 Inactive (7)

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01 Complete (11)

02 Blank (19)

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ZHEJIANG APELOA KANGY...
Active
25151
Complete
2015-12-04
2015-04-28
2011-07-21
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ZHEJIANG APELOA JIAYU...
Active
22809
N/A
2009-05-08
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ZHEJIANG APELOA JIAYU...
Active
18200
Complete
2014-02-18
2014-01-28
2005-03-22
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ZHEJIANG APELOA JIAYU...
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25464
N/A
2011-10-20
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ZHEJIANG APELOA JIAYU...
Inactive
35052
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2020-08-01
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ZHEJIANG APELOA JIAYU...
Active
38624
Complete
2023-10-26
2023-08-17
2023-08-01
II
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ZHEJIANG APELOA KANGY...
Active
34902
N/A
2020-08-26
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ZHEJIANG APELOA JIAYU...
Active
24752
Complete
2013-10-31
2013-07-29
2011-03-08
II
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ZHEJIANG APELOA JIAYU...
Active
29214
N/A
2015-03-20
II
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ZHEJIANG APELOA JIAYU...
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26304
N/A
2012-07-30
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