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

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01 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVNA) (1)

02 CEFDINIR HYDRATE USP (1)

03 CEFDINIR USP (1)

04 CEFIXIME USP (1)

05 CEFPODOXIME PROXETIL USP (1)

06 CEFPROZIL USP (1)

07 CEFUROXIME ACID (1)

08 CEFUROXIME ACID (ACETONE ROUTE) (1)

09 CEFUROXIME AXETIL USP (AMORPHOUS) (1)

10 CEFUROXIME AXETIL USP (CRYSTALLINE) (1)

11 GABAPENTIN USP (1)

12 RANITIDINE HCI (FORM-I) (1)

13 RANITIDINE HYDROCHLORIDE (FORM-II) (1)

14 SULFADIAZINE USP (1)

15 SULFAMETHOXAZOLE USP (1)

16 TRIMETHOPRIM USP (1)

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01 ANDHRA ORGANICS LTD (2)

02 COVALENT LABORATORIES PRIVATE LTD (10)

03 SARACA LABORATORIES LTD (3)

04 VIRCHOW LABORATORIES LTD (1)

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01 India (16)

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01 Active (12)

02 Inactive (4)

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01 Complete (8)

02 Blank (8)

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COVALENT LABORATORIES...
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23373
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2009-11-23
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COVALENT LABORATORIES...
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30320
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2017-01-13
2016-07-19
2016-02-22
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COVALENT LABORATORIES...
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25882
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2017-03-07
2016-10-19
2012-03-19
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COVALENT LABORATORIES...
Active
27121
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2017-03-28
2016-10-19
2013-04-29
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COVALENT LABORATORIES...
Active
29791
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2017-02-27
2016-12-27
2015-09-14
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COVALENT LABORATORIES...
Active
29383
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2017-07-11
2017-05-31
2015-05-15
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COVALENT LABORATORIES...
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24495
N/A
2010-12-28
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COVALENT LABORATORIES...
Active
25075
Complete
2016-06-10
2016-05-19
2011-06-24
II
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COVALENT LABORATORIES...
Inactive
23237
N/A
2009-10-23
II
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SARACA LABORATORIES L...
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30809
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2017-07-13
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