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Drug Product Composition: Amlodipine Besylate

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

USFDA APPLICATION NUMBER - 19787 / DOSAGE - TABLET;ORAL - EQ 5MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288)
AMLODIPINE10mg

Inactive Ingredients

Ingredient Name
American Health Packaging
Aurobindo Pharma Limited
Avera McKennan Hospital
Bryant Ranch Prepack
Cardinal Health
Clinical Solutions Wholesale
Clinical Solutions Wholesale, LLC
Contract Pharmacy Services-PA
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Exelan Pharmaceuticals, Inc.
KAISER FOUNDATION HOSPITALS
Lake Erie Medical DBA Quality Care Products LLC
Legacy Pharmaceutical Packaging, LLC
Lupin Pharmaceuticals, Inc.
McKesson Contract Packaging
Medsource Pharmaceuticals
Mylan Institutional Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
New Horizon Rx Group, LLC
NuCare Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceutical Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
QPharma Inc
Quality Care Products, LLC
RedPharm Drug, Inc.
REMEDYREPACK INC.
Rising Pharmaceuticals, Inc.
St Marys Medical Park Pharmacy
Teva Pharmaceuticals USA, Inc.
Torrent Pharmaceuticals Limited
Unichem Pharmaceuticals (USA), Inc.
Unit Dose Services
Vivimed Labs Limited
Wock
State of Florida DOH Central Pharmacy
A-S Medication Solutions
Amneal Pharmaceuticals LLC
DIRECT RX
Macleods Pharmaceuticals Limited
Major Pharmaceuticals
Par Pharmaceutical
Safecor Health, LLC
TYA Pharmaceuticals
Apotex Corp.
AvPAK
DOH CENTRAL PHARMACY
Hikma Pharmaceutical
Hikma Pharmaceuticals USA Inc.
Marlex Pharmaceuticals Inc
medsource pharmaceuticals
Physicians Total Care, Inc.
State of
Aphena Pharma Solutions - Tennessee, LLC
Mylan Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Upsher-Smith Laboratories, LLC
West-Ward Pharmaceuticals Corp.
Blenheim Pharmacal, Inc.
Cardinal Health 107, LLC
Epic Pharma, LLC
Golden State Medical Supply, Inc.
McKesson Corporation dba SKY Packaging
NCS HealthCare of KY, Inc dba Vangard Lab
Wockhardt USA LLC.
Zydus Pharmaceuticals USA Inc.
Par Phar
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                                
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)                                                                   
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)                                                   
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)                                                                   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                              
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                                                       
FD&C BLUE NO. 2(L06K8R7DQK)                                                             
FD&C RED NO. 40(WZB9127XOA)                                                                   
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                                                                  
MAGNESIUM STEARATE(70097M6I30)                                
MANNITOL(3OWL53L36A)                                                                 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                                             
POVIDONE(FZ989GH94E)                                                                  
SILICON DIOXIDE(ETJ7Z6XBU4)                                              
SODIUM LAURYL SULFATE(368GB5141J)                                                             
SODIUM STARCH GLYCOLATE TYPE A POTATO (5856J3G2A2)                                                                  
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                                
SODIUM STARCH GLYCOLATE TYPE B POTATO(27NA468985)                                                                  
STARCH, CORN(O8232NY3SJ)                                                      
STEARIC ACID(4ELV7Z65AP)