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Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Sanum-kehlbeck Gmbh & Co. Kg to the U.S. FDA. Original Data : FDA Website

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01 ALPROSTADIL (1)

02 AZACYTIDINE (1)

03 AZITHROMYCIN MONOHYDRATE (1)

04 BENDAMUSTINE HYDROCHLORIDE (1)

05 CALCITONIN SALMON USP (1)

06 CARBOPROST TROMETHAMINE (1)

07 DECITABINE (1)

08 DEGARELIX (1)

09 DESMOPRESSIN ACETATE USP (1)

10 ETELCALCETIDE HYDROCHLORIDE (1)

11 GANIRELIX ACETATE (1)

12 GLATIRAMER ACETATE (1)

13 ICATIBANT ACETATE (1)

14 LANSOPRAZOLE (1)

15 LEUPROLIDE ACETATE USP (1)

16 LEVOFLOXACIN HEMIHYDRATE (1)

17 LINACLOTIDE (1)

18 LIRAGLUTIDE (1)

19 MOXIFLOXACIN HYDROCHLORIDE (1)

20 OCTREOTIDE ACETATE (1)

21 P-542, SODIUM SALT OF POLACRYLIC ACID (1)

22 P-544D - POTASSIUM SALT OF POLACRYLIC ACID WITH PERCENTAGE OF POTASSIUM TO EXTENT OF 24.5-25.5% (1)

23 P-544S - POTASSIUM SALT OF POLACRYLIC ACID WITH PERCENTAGE OF POTASSIUM TO EXTENT OF 17-20% (1)

24 PAROXETINE HYDROCHLORIDE HEMIHYDRATE (1)

25 PEMETREXED DISODIUM EP (1)

26 PLECANATIDE (1)

27 ROSIGLITAZONE MALEATE (1)

28 SODIUM RISEDRONATE AMORPHOUS (1)

29 TEMOZOLOMIDE, USP (1)

30 TERIPARATIDE (1)

31 TOLTERODINE L-TARTRATE (1)

32 TREPROSTINIL DIETHANOLAMINE (1)

33 VASOPRESSIN USP (1)

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01 AURO PEPTIDES LTD (14)

02 DOSHION LTD (3)

03 ITF CHEMICAL LTDA (13)

04 TIEN TIANJIN PHARMACEUTICAL CO LTD (3)

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01 Brazil (13)

02 China (3)

03 India (17)

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01 Active (22)

02 Inactive (11)

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01 Complete (17)

02 Blank (16)

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TIEN TIANJIN PHARMACE...
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34239
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2020-04-21
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ITF CHEMICAL LTDA
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27953
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2014-08-27
2014-07-01
2014-03-18
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ITF CHEMICAL LTDA
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17010
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2005-02-28
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ITF CHEMICAL LTDA
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28418
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2014-07-29
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AURO PEPTIDES LTD
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35791
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2021-04-22
2021-03-30
2021-03-30
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TIEN TIANJIN PHARMACE...
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36373
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2021-10-14
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ITF CHEMICAL LTDA
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26708
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2013-07-08
2013-01-18
2012-12-11
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AURO PEPTIDES LTD
Active
35078
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2020-09-08
2020-08-07
2020-08-07
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AURO PEPTIDES LTD
Active
30233
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2016-03-30
2016-02-17
2016-02-19
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AURO PEPTIDES LTD
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35386
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2021-01-11
2020-11-12
2020-11-12
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