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Drug Product Composition: Simvastatin

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$ API Ref.Price (USD/KG) : 226Xls

USFDA APPLICATION NUMBER - 19766 / DOSAGE - TABLET;ORAL - 10MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV)
SIMVASTATIN20mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Aphena Pharma Solutions - Tennessee, LLC
Biocon Pharma Inc,
Bryant Ranch Prepack
Cardinal Health
Northwind Pharmaceuticals, LLC
PuraCap Laboratories LLC dba Blu Pharmaceuticals
PuraCap Laboratories, LLC
State of Florida DOH Central Pharmacy
International Laboratories, LLC
Lake Erie Medical DBA Quality Care Products LLC
Major Pharmaceuticals
McKesson Contract Packaging
McKesson Corporation dba SKY Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
NuCare Pharmaceuticals,Inc.
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
Contract Pharmacy Services-PA
ACETRIS HEALTH, LLC
Actavis Pharma, Inc.
Aidarex Pharmaceuticals LLC
Avera McKennan Hospital
AvPAK
Blenheim Pharmacal, Inc.
Carilion Materials Management
Clinical Solutions Wholesale
Clinical Solutions Wholesale, LLC
Cobalt Laboratories Inc.
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Direct Rx
Direct_Rx
Ingenus Pharmaceuticals, LLC
KAISER FOUNDATION HOSPITALS
Legacy Pharmaceutical Packaging, LLC
MedVantx, Inc.
Merck Sharp & Dohme Corp.
Mylan Institutional Inc.
Northwind Pharmaceuticals
NuCare Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals, Inc.
NuC
PD-Rx Pharmace
REMEDYRE
Proficient Rx LP
QPharma
St Marys Medical Park Pharmacy
Unit Dose Services
Preferred Pharmace
QPharma Inc
Safecor Health, LLC
Teva Pharmaceuticals USA, Inc.
Preferred Pharma
PD-Rx Pharmaceuticals, Inc
PuraCap Laboratorie
ALCOHOL(3K9958V90M)                                                
ANHYDROUS CITRIC ACID(XF417D3PSL)                                      
ANHYDROUS LACTOSE(3SY5LH9PMK)                                                   
ASCORBIC ACID(PQ6CK8PD0R)                    
BUTYLATED HYDROXYANISOLE(REK4960K2U)                    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                     
CITRIC ACID ACETATE(DSO12WL7AU)                                                        
CITRIC ACID ANHYDROUS(XF417D3PSL)                                                        
CITRIC ACID MONOHYDRATE(2968PHW8QP)                     
CITRIC ACID(2968PHW8QP)                                                        
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                                                        
CROSCARMELLOSE SODIUM(M28OL1HH48)                                 
FD&C RED NO. 40(WZB9127XOA)                                                       
FERRIC OXIDE RED(1K09F3G675)                    
Ferric Oxide Yellow(EX438O2MRT)                         
FERROSOFERRIC OXIDE(XM0M87F357)                                       
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)                                                    
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                                                    
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                                           
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                                    
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                                               
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                                         
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                                    
HYPROMELLOSE(3NXW29V3WO)                                                      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                                                   
HYPROMELLOSES(3NXW29V3WO)                                 
ISOPROPYL ALCOHOL(ND2M416302)                                          
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                    
LACTOSE(J2B2A4N98G)                                                        
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                                                        
MAGNESIUM STEARATE(70097M6I30)                    
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                                             
POLYDEXTROSE(VH2XOU12IE)                                                       
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                                            
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                                              
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                                                      
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                                                        
POVIDONE(FZ989GH94E)                                                     
POVIDONE, UNSPECIFIED(FZ989GH94E)                                                      
POVIDONES(FZ989GH94E)                                                       
SILICON DIOXIDE(ETJ7Z6XBU4)                                                 
STARCH, CORN(O8232NY3SJ)                     
Starch, Pregelatinized Corn(O8232NY3SJ)                                                  
TALC(7SEV7J4R1U)                     
TITANIUM DIOXIDE(15FIX9V2JP)                    
TRIACETIN(XHX3C3X673)                                         
TRIETHYL CITRATE(8Z96QXD6UM)