Varenicline Tartrate

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 20 USDMF, 1 JDMF, 8 EU WC, 7 KDMF, 12 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

84 FDF Dossiers, 35 FDA Orange Book, 14 Europe, 6 Canada, 11 Australia, 8 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 3 DKSH, 2 Faran Shimi Pharmaceutical, 7 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 25 Fillers, Diluents & Binders, 24 Controlled & Modified Release, 16 Direct Compression, 16 Thickeners and Stabilizers, 15 Disintegrants & Superdisintegrants, 11 Lubricants & Glidants, 10 Granulation, 8 Film Formers & Plasticizers, 8 Co-Processed Excipients, 7 Topical, 5 Empty Capsules, 5 Solubilizers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 3 Rheology Modifiers, 2 Parenteral

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 72 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 11 Finished Drug Prices, 9 Annual Reports

MARKET PLACE

14 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 1 US Exclusivities, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

19 Others

19 Others

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USFDA APPLICATION NUMBER - 21928 / DOSAGE - TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
varenicline tartrate(UNII: 82269ASB48) (varenicline - UNII:W6HS99O8ZO)	varenicline	0.5mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Cardinal Health	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC
anhydrous dibasic calcium phosphate(L11K75P92J)
cellulose, microcrystalline(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
silicon dioxide(ETJ7Z6XBU4)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Varenicline Tartrate