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

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01 2,5-PYRIDINEDICARBOXYLIC ACID,1-(2,2-DIMETHOXYETHYL)-1,4-DIHYDRO-3-METHOXY-4-OXO-, 2-METHYL ESTER (1)

02 ABIRATERONE ACETATE (1)

03 ATAZANAVIR SULFATE (1)

04 ATAZANAVIR SULPHATE [DRUG SUBSTANCE (NON-STERILE)] (1)

05 ATOVAQUONE (1)

06 CABOTEGRAVIR SODIUM (1)

07 CANAGLIFLOZIN (1)

08 CAPECITABINE USP [DRUG SUBSTANCE (NON-STERILE)] (1)

09 DABIGATRAN ETEXILATE MESYLATE [DRUG SUBSTANCE (NON-STERILE)] (1)

10 DASATINIB (1)

11 DASATINIB [DRUG SUBSTANCE (NON-STERILE)] (1)

12 DOLUTEGRAVIR SODIUM (1)

13 EDOXABAN TOSYLATE MONOHYDRATE (1)

14 EFAVIRENZ USP (1)

15 EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)] (1)

16 ELAGOLIX SODIUM (1)

17 ELVITEGRAVIR (1)

18 EMTRICITABINE (1)

19 ENZALUTAMIDE (1)

20 ERLOTINIB HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) (1)

21 ERLOTINIB HYDROCHLORIDE [DRUG SUBSTANCE (NON-STERILE)] (1)

22 IMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)] (1)

23 IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)] (1)

24 LAMIVUDINE USP (1)

25 LOPINAVIR (1)

26 LOPINAVIR HYDRATE (1)

27 LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)] (1)

28 LUMEFANTRINE (1)

29 MEFLOQUINE HYDROCHLORIDE (1)

30 NEVIRAPINE USP (1)

31 OSELTAMIVIR PHOSPHATE (1)

32 PALBOCICLIB (NON-STERILE DRUG SUBSTANCE) (1)

33 PAZOPANIB HCL (NON-STERILE DRUG SUBSTANCE) (1)

34 PEMETREXED DISODIUM HEMIPENTA HYDRATE [DRUG SUBSTANCE (NON-STERILE)] (1)

35 PRAZIQUANTEL (1)

36 RILPIVIRINE HYDROCHLORIDE (2)

37 RITONAVIR USP (1)

38 ROSUVASTATIN CALCIUM (1)

39 STAVUDINE USP (1)

40 SUNITINIB MALATE (1)

41 TENOFOVIR (1)

42 TENOFOVIR ALAFENAMIDE FUMARATE (1)

43 TENOFOVIR ALAFENAMIDE FUMARATE [DRUG SUBSTANCE (NON-STERILE)]. (1)

44 TENOFOVIR DISOPROXIL FUMARATE (1)

45 TENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)] (1)

46 ZIDOVUDINE USP (1)

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01 ACEBRIGHT INDIA PHARMA PRIVATE LTD (9)

02 CDYMAX INDIA PHARMA PRIVATE LTD (10)

03 SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD (28)

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01 China (28)

02 India (19)

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01 Active (43)

02 Inactive (4)

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01 Complete (21)

02 Blank (26)

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SHANGHAI DESANO CHEMI...
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34984
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2020-06-28
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CDYMAX INDIA PHARMA P...
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36670
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2022-01-06
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SHANGHAI DESANO CHEMI...
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26672
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2012-11-20
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ACEBRIGHT INDIA PHARM...
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28952
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2014-12-23
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SHANGHAI DESANO CHEMI...
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25305
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2011-09-13
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SHANGHAI DESANO CHEMI...
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37452
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2022-09-14
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SHANGHAI DESANO CHEMI...
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30366
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2015-12-31
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CDYMAX INDIA PHARMA P...
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25054
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2017-02-06
2016-09-09
2011-06-14
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ACEBRIGHT INDIA PHARM...
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35360
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2020-10-31
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CDYMAX INDIA PHARMA P...
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37942
Complete
2024-04-11
2024-04-03
2023-01-16
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