Amlodipine Besylate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

110 API Suppliers, 41 USDMF, 43 CEP/COS, 25 JDMF, 25 EU WC, 92 KDMF, 26 NDC API, 54 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

765 FDF Dossiers, 424 FDA Orange Book, 47 Europe, 134 Canada, 34 South Africa, 126 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE, CAPSULE;ORAL - EQ 10MG BASE;20MG, CAPSULE;ORAL - EQ 10MG BASE;40MG, CAPSULE;ORAL - EQ 2.5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;10MG, CAPSULE;ORAL - EQ 5MG BASE;20MG, CAPSULE;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;14MG, TABLET;ORAL - EQ 2.5MG BASE;3.5MG, TABLET;ORAL - EQ 5MG BASE;7MG, TABLET;ORAL - EQ 10MG BASE;200MG, TABLET;ORAL - EQ 2.5MG BASE;200MG, TABLET;ORAL - EQ 5MG BASE;200MG, TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE, TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;20MG, TABLET;ORAL - EQ 10MG BASE;40MG, TABLET;ORAL - EQ 5MG BASE;20MG, TABLET;ORAL - EQ 5MG BASE;40MG, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Rochem International Inc, 21 SPI Pharma, 2 Seqens, 19 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 3 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 35 BASF, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

113 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 55 Direct Compression, 48 Disintegrants & Superdisintegrants, 43 Thickeners and Stabilizers, 38 Solubilizers, 35 Controlled & Modified Release, 33 Lubricants & Glidants, 32 Granulation, 27 Topical, 24 Parenteral, 24 Film Formers & Plasticizers, 22 Co-Processed Excipients, 21 Chewable & Orodispersible Aids, 19 Taste Masking, 13 Emulsifying Agents, 10 API Stability Enhancers, 10 Rheology Modifiers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 40 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

35 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

33 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 1 USP, 7 JP, 1 Others

$ Xls

Filters

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USFDA APPLICATION NUMBER - 19787 / DOSAGE - TABLET;ORAL - EQ 10MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10mg

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)

Drug Product Composition: Amlodipine Besylate