Vardenafil Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 6 USDMF, 5 CEP/COS, 2 JDMF, 3 EU WC, 2 KDMF, 23 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

10 Drugs in Development

10 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 32 FDA Orange Book, 155 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TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 15 SPI Pharma, 5 DKSH, 4 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 Esteem Industries, 1 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 11 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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 Silverline Chemicals, 2 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives, 41 Fillers, Diluents & Binders, 18 Direct Compression, 18 Controlled & Modified Release, 17 Taste Masking, 17 Thickeners and Stabilizers, 17 Chewable & Orodispersible Aids, 13 Film Formers & Plasticizers, 11 Granulation, 10 Lubricants & Glidants, 9 Co-Processed Excipients, 9 Disintegrants & Superdisintegrants, 8 Topical, 6 Solubilizers, 6 Parenteral, 5 Empty Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 1 Soft Gelatin

DIGITAL CONTENT

19 News #PharmaBuzz

19 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 26 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

13 APIs

13 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

13 Others

13 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21400 / DOSAGE - TABLET;ORAL - EQ 10MG 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
VARDENAFIL HYDROCHLORIDE TRIHYDRATE(UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)	VARDENAFIL HYDROCHLORIDE TRIHYDRATE	20mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	KAISER FOUNDATION HOSPITALS	PD-Rx Pharmaceuticals, Inc.	GlaxoSmithKline LLC
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(68401960MK)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 3cded133 C2a9 41fa 94e2 6f468fa8b9a1 Applno 21400 Form Tablet Oral Dosage Eq 10mg Base - Drug Product Composition: Vardenafil Hydrochloride