benzenesulfonic acid; 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate | 20364 | CAPSULE;ORAL | EQ 10MG BASE;40MG

benzenesulfonic acid;3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

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BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for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

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USFDA APPLICATION NUMBER - 20364 / DOSAGE - CAPSULE;ORAL - EQ 10MG BASE;40MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE BESYLATE	2.5mg
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T) (BENAZEPRIL - UNII:UDM7Q7QWP8)	BENAZEPRIL HYDROCHLORIDE	10mg

Inactive Ingredients

Ingredient Name	Apotex Corp.	Bryant Ranch Prepack	NuCare Pharmaceuticals,Inc.	PD-Rx Pharmaceuticals, Inc.	Teva Pharmaceuticals USA, Inc.	A-S Medication Solutions	Actavis Pharma, Inc.	BluePoint Laboratories	Lupin Pharmaceuticals, Inc.	Mylan Pharmaceuticals Inc.	Proficient Rx LP	Cardinal Health	Clinical Solutions Wholesale	Lake Erie Medical DBA Quality Care Products LLC	NCS HealthCare of KY, Inc dba Vangard Labs	Sandoz Inc	NuCare Pharmaceuticals, Inc.	Aidarex Pharmaceuticals LLC	NuCare Pharmaceuticals, Inc.	Par Pharmaceutical Inc.	Rebel Distributors Corp	REMEDYREPACK INC.
Ammonia(5138Q19F1X)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CALCIUM PHOSPHATE(97Z1WI3NDX)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
CROSPOVIDONE, UNSPECIFIED(2S7830E561)
D&C RED NO. 28(767IP0Y5NH)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 3(PN2ZH5LOQY)
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)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROGENATED CASTOR OIL(ZF94AP8MEY)
HYPROMELLOSE(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
Propylene glycol(6DC9Q167V3)
Shellac(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: benzenesulfonic acid; 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate