ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
01 2ASolution Pharmaceuticals
02 2Fermion Oy
03 2Actavis Inc
04 2Alembic Pharmaceuticals Limited
05 1Assia Chemical Industries Ltd
06 2Cambrex Corporation
07 3F.I.S. Fabbrica Italiana Sintetici
08 3Jinan Jinda Pharmaceutical Chemistry Co Ltd
09 1Lek Pharmaceuticals
10 2Macleods Pharmaceuticals Limited
11 3Maithri Drugs
12 2Mankind Pharma
13 2Omsav Pharma Research
14 1PCA - Prodotti Chimicie Alimentari S.p.A
15 1Roche Diagnostics GmbH
16 1Sandoz B2B
17 4Unimark Remedies Limited
01 1FDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY MONOTHERAPY CLINICAL TRIALS
02 1MANUFACTURE OF NITROFURANTOIN
03 2NITROFURANTOIN
04 1NITROFURANTOIN MONOHYDRATE USP
05 1NITROFURANTOIN & NITROFURANTOIN MACROCRYSTALS
06 1NITROFURANTOIN ANHYDROUS
07 1NITROFURANTOIN ANHYDROUS (MACROCRYSTAL)
08 1NITROFURANTOIN ANHYDROUS CRYSTALS USP
09 2NITROFURANTOIN ANHYDROUS USP
10 2NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)
11 1NITROFURANTOIN HYDROUS USP
12 1NITROFURANTOIN MACROCRYSTAL
13 1NITROFURANTOIN MACROCRYSTAL USP
14 1NITROFURANTOIN MACROCRYSTALLINE
15 2NITROFURANTOIN MACROCRYSTALS
16 3NITROFURANTOIN MACROCRYSTALS USP
17 6NITROFURANTOIN MONOHYDRATE
18 1NITROFURANTOIN MONOHYDRATE (CODE 1042-1026)
19 4NITROFURANTOIN MONOHYDRATE USP
20 1NITROFURANTOIN U.S.P
01 3China
02 2Finland
03 1Germany
04 17India
05 2Ireland
06 1Israel
07 4Italy
08 1Slovenia
09 1Switzerland
10 2U.S.A
01 26Active
02 8Inactive
01 16Complete
02 18Blank
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38079
Submission : 2023-05-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-15
Pay. Date : 2019-11-05
DMF Number : 33838
Submission : 2019-10-15
Status : Active
Type : II
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38080
Submission : 2023-05-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-27
Pay. Date : 2019-12-02
DMF Number : 33839
Submission : 2019-11-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15504
Submission : 2001-07-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16505
Submission : 2003-04-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-08
Pay. Date : 2014-12-18
DMF Number : 21887
Submission : 2008-08-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-10
DMF Number : 13266
Submission : 1998-10-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-21
DMF Number : 453
Submission : 1965-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23500
Submission : 2010-02-16
Status : Active
Type : II
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