Amlodipine Besylate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

112 API Suppliers, 41 USDMF, 44 CEP/COS, 25 JDMF, 26 EU WC, 92 KDMF, 26 NDC API, 55 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

767 FDF Dossiers, 424 FDA Orange Book, 47 Europe, 134 Canada, 34 South Africa, 128 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BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 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, 11 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, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

110 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 54 Direct Compression, 47 Disintegrants & Superdisintegrants, 43 Thickeners and Stabilizers, 37 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 Rheology Modifiers, 10 API Stability Enhancers, 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

Xls

USFDA APPLICATION NUMBER - 22314 / DOSAGE - TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	160mg

Inactive Ingredients

Ingredient Name	Teva Pharmaceuticals USA, Inc.	Lupin Pharmaceuticals, Inc.	Par Pharmaceutical, Inc.	REMEDYREPACK INC.	Torrent Pharmaceuticals Limited	Sandoz Inc
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 2(L06K8R7DQK)
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)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYSORBATE 20(7T1F30V5YH)
POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Amlodipine Besylate