Isosorbidi nitras

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 15 USDMF, 3 CEP/COS, 5 JDMF, 7 KDMF, 3 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

120 FDF Dossiers, 65 FDA Orange Book, 26 Europe, 4 Canada, 2 Australia, 13 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, TABLET;ORAL - 37.5MG;20MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 9 DKSH, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 13 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 29 Thickeners and Stabilizers, 27 Direct Compression, 24 Granulation, 21 Controlled & Modified Release, 17 Disintegrants & Superdisintegrants, 16 Lubricants & Glidants, 15 Solubilizers, 12 Film Formers & Plasticizers, 12 Topical, 11 Co-Processed Excipients, 10 Taste Masking, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 8 Parenteral, 8 Emulsifying Agents, 5 API Stability Enhancers, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

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9 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 25 Regulatory FDF Prices

MARKET PLACE

11 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM

2 EDQM

$ Xls

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USFDA APPLICATION NUMBER - 19790 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOSORBIDE DINITRATE(UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)	ISOSORBIDE DINITRATE	40mg

Inactive Ingredients

Ingredient Name	Endo Pharmaceuticals, Inc.
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10(35SW5USQ3G)
ETHYLCELLULOSES(7Z8S9VYZ4B)
GELATIN(2G86QN327L)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Isosorbidi nitras