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Drug Product Composition: Amlodipine Besylate

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

USFDA APPLICATION NUMBER - 22100 / DOSAGE - TABLET;ORAL - EQ 10MG BASE;40MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288)
AMLODIPINE10mg | 5mg | 10mg | 5mg
OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD)
(OLMESARTAN - UNII:8W1IQP3U10)
OLMESARTAN MEDOXOMIL40mg | 40mg | 20mg | 20mg

Inactive Ingredients

Ingredient Name
Aurobindo Pharma Limited
Bryant Ranch Prepack
Jubilant Cadista Pharmaceuticals Inc.
Alembic Pharmaceuticals Inc.
Apotex Corp.
medsource pharmaceuticals
Micro Labs Limited
Physicians Total Care, Inc.
Ajanta Pharma USA Inc.
Ascend Laboratories, LLC
AvKARE, Inc.
Glenmark Pharmaceuticals Inc., USA
ScieGen Pharmaceuticals, Inc
Torrent Pharmaceuticals Limited
Teva Pharmaceuticals USA, Inc.
Anhydrous Lactose(3SY5LH9PMK)            
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
CROSCARMELLOSE SODIUM(M28OL1HH48) 
CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9)             
FD&C BLUE NO. 1(H3R47K3TBD)              
FD&C RED NO. 40(WZB9127XOA)             
FD&C YELLOW NO. 5(I753WB2F1M)              
FD&C YELLOW NO. 6(H77VEI93A8)             
Ferric Oxide Red(1K09F3G675) 
FERRIC OXIDE YELLOW(EX438O2MRT) 
FERROSOFERRIC OXIDE(XM0M87F357)       
HYDROGENATED CASTOR OIL(ZF94AP8MEY)            
LACTOSE MONOHYDRATE(EWQ57Q8I5X)          
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)             
MEGLUMINE(6HG8UB2MUY)              
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)       
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)     
POLYETHYLENE GLYCOL 400(B697894SGQ)             
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)             
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)             
POLYVINYL ALCOHOL(532B59J990)           
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)      
POVIDONE K30(U725QWY32X)            
POVIDONE(FZ989GH94E)              
Powdered Cellulose(SMD1X3XO9M)              
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM HYDROXIDE(55X04QC32I)             
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)            
SODIUM STEARYL FUMARATE(7CV7WJK4UI)              
STARCH, CORN(O8232NY3SJ)    
STARCH, POTATO(8I089SAH3T)              
STEARIC ACID(4ELV7Z65AP)              
SUCCINIMIDYL-4-(N-MALEIMIDOMETHYL)CYCLOHEXANE-1-CARBOXYLATE(B357P1G1IF)              
Talc(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)