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Drug Product Composition: Amlodipine Besylate

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$ API Ref.Price (USD/KG) : 117Xls

USFDA APPLICATION NUMBER - 21990 / DOSAGE - TABLET;ORAL - EQ 10MG BASE;320MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288)
AMLODIPINE5mg
VALSARTAN(UNII: 80M03YXJ7I)
(VALSARTAN - UNII:80M03YXJ7I)
VALSARTAN160mg

Inactive Ingredients

Ingredient Name
Teva Pharmaceuticals USA, Inc.
AvKARE, Inc.
Novel Laboratories, Inc.
REMEDYREPACK INC.
Trigen Laboratories, LLC
Torrent Pharmaceuticals Limited
A-S Medication Solutions
Sandoz Inc
Alembic Pharmaceuticals Inc.
Alembic Pharmaceuticals Limited
Aurobindo Pharma Limited
LUPIN LIMITED
Lupin Pharmaceuticals, Inc.
medsource pharmaceuticals
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)             
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)          
CROSCARMELLOSE SODIUM(M28OL1HH48)             
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)          
CROSPOVIDONE(2S7830E561)             
CROSPOVIDONE(68401960MK)          
D&C YELLOW NO. 10(35SW5USQ3G)             
FD&C BLUE NO. 2(L06K8R7DQK)             
FD&C RED NO. 40(WZB9127XOA)             
FD&C YELLOW NO. 6(H77VEI93A8)             
FERRIC OXIDE RED(1K09F3G675)      
FERRIC OXIDE YELLOW(EX438O2MRT)     
FERROSOFERRIC OXIDE(XM0M87F357)             
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)         
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)            
HYPROMELLOSES(3NXW29V3WO)             
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)             
MAGNESIUM STEARATE(70097M6I30)   
MANNITOL(3OWL53L36A)           
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)        
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)            
POLYETHYLENE GLYCOL 400(B697894SGQ)             
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)             
POLYETHYLENE GLYCOL 6000(30IQX730WE)           
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)           
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)            
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)             
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)             
POVIDONE K30(U725QWY32X)            
SILICON DIOXIDE(ETJ7Z6XBU4)    
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)        
STARCH, CORN(O8232NY3SJ)            
TALC(7SEV7J4R1U)     
TITANIUM DIOXIDE(15FIX9V2JP)