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Drug Product Composition: Fenofibric Acid

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$ API Ref.Price (USD/KG) : 84Xls

USFDA APPLICATION NUMBER - 21656 / DOSAGE - TABLET;ORAL - 145MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE(UNII: U202363UOS)
(FENOFIBRATE - UNII:U202363UOS)
FENOFIBRATE145mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Bryant Ranch Prepack
NuCare Pharmaceuticals,Inc.
Perrigo New York Inc
Preferred Pharmaceuticals Inc.
Avera McKennan Hospital
Cardinal Health
Cipla USA Inc.
Graviti Pharmaceuticals Private Limited
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
Laurus Labs Limited
Leading Pharma, LLC
Northwind Pharmaceuticals, LLC
NuCare Pharmaceuticals, Inc.
Teva Pharmaceuticals USA Inc
Zydus Pharmaceuticals USA Inc
NorthStar Rx LLC
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
American Health Packaging
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Golden State Medical Supply, Inc.
Major Pharmaceuticals
Solco Healthcare US, LLC
Sun Pharmaceutical Industries, Inc.
Unit Dose Services
Alembic Pharmaceuticals Inc.
A-S Medication Solutions LLC
AvPAK
LUPIN LIMITED
ANHYDROUS LACTOSE(3SY5LH9PMK)                          
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                 
CROSCARMELLOSE SODIUM(M28OL1HH48)                          
CROSPOVIDONE (120 .MU.M)(68401960MK)                          
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                
CROSPOVIDONE(2S7830E561)                            
CROSPOVIDONE(68401960MK)                     
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                              
D&C YELLOW NO. 10(35SW5USQ3G)                 
DIMETHICONE(92RU3N3Y1O)                              
DOCUSATE SODIUM(F05Q2T2JA0)               
FD&C BLUE NO. 2(L06K8R7DQK)                 
FD&C YELLOW NO. 6(H77VEI93A8)                 
FERRIC OXIDE RED(1K09F3G675)                              
FERRIC OXIDE YELLOW(EX438O2MRT)                          
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                            
HYPROMELLOSE 2910 (3 CPS)(0VUT3PMY82)                              
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)              
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                            
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                  
HYPROMELLOSES(3NXW29V3WO)                          
LACTOSE MONOHYDRATE(EWQ57Q8I5X)       
LECITHIN, SOYBEAN(1DI56QDM62)          
MAGNESIUM STEARATE(70097M6I30)   
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                 
POLACRILIN POTASSIUM(0BZ5A00FQU)                            
POLOXAMER 407(TUF2IVW3M2)                            
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                              
POLYETHYLENE GLYCOL 400(B697894SGQ)                           
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)                              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                             
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                              
POLYVINYL ALCOHOL(532B59J990)                       
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)           
SILICON DIOXIDE(ETJ7Z6XBU4)               
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)                        
STARCH, CORN(O8232NY3SJ)                        
SUCROSE(C151H8M554)  
TALC(7SEV7J4R1U)    
TITANIUM DIOXIDE(15FIX9V2JP)  
WATER(059QF0KO0R)                          
XANTHAN GUM(TTV12P4NEE)