Vardenafil Hydrochloride

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 6 USDMF, 5 CEP/COS, 2 JDMF, 8 EU WC, 2 KDMF, 9 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

102 FDF Dossiers, 32 FDA Orange Book, 39 Europe, 6 Canada, 5 South Africa, 20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 3 DKSH, 7 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 3 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 24 Controlled & Modified Release, 22 Direct Compression, 17 Thickeners and Stabilizers, 16 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Film Formers & Plasticizers, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Granulation, 8 Parenteral, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 26 Finished Drug Prices, 2 Annual Reports

MARKET PLACE

12 APIs

12 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 11 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 200179 / DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **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
VARDENAFIL HYDROCHLORIDE(UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)	VARDENAFIL	11.85mg

Inactive Ingredients

Ingredient Name	GlaxoSmithKline LLC
ASPARTAME(Z0H242BBR1)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
SILICON DIOXIDE(ETJ7Z6XBU4)
SORBITOL(506T60A25R)

Drug Product Composition: Vardenafil Hydrochloride