NITROFURANTOIN MACROCRYSTALLINE

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

72 API Suppliers, 32 USDMF, 13 CEP/COS, 8 EU WC, 26 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

143 FDF Dossiers, 74 FDA Orange Book, 25 Europe, 9 Canada, 4 Australia, 12 South Africa, 19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG, CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 50MG, CAPSULE;ORAL - 75MG;25MG, SUSPENSION;ORAL - 25MG/5ML, SUSPENSION;ORAL - 50MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 7 SPI Pharma, 14 DKSH, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 15 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 15 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 15 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 41 Thickeners and Stabilizers, 32 Direct Compression, 28 Granulation, 26 Controlled & Modified Release, 21 Taste Masking, 18 Film Formers & Plasticizers, 18 Solubilizers, 15 Lubricants & Glidants, 13 Parenteral, 12 Topical, 11 Co-Processed Excipients, 10 Chewable & Orodispersible Aids, 10 Disintegrants & Superdisintegrants, 10 Rheology Modifiers, 9 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 4 Vegetarian Capsules, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

32 News #PharmaBuzz

32 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 14 Regulatory FDF Prices

MARKET PLACE

31 APIs, 11 FDF Dossiers

REF. STANDARDS & IMPURITIES

6 Others

6 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

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USFDA APPLICATION NUMBER - 9175 / DOSAGE - SUSPENSION;ORAL - 25MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NITROFURANTOIN(UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)	NITROFURANTOIN	25mg in 5

Inactive Ingredients

Ingredient Name	Caraco Pharmaceutical Laboratories, Ltd.	Shionogi Inc.	Prasco Laboratories
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
FRUIT(C2AIY4ERZC)
GLYCERIN(PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE(6M3P64V0NC)
METHYLPARABEN(A2I8C7HI9T)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SORBITOL(506T60A25R)
SUCRALOSE(96K6UQ3ZD4)
WATER(059QF0KO0R)

Setid 6bdf87ae Daf1 4912 9d45 E06fa9eaaf1a Applno 9175 Form Suspension Oral Dosage 25mg 5ml - Drug Product Composition: NITROFURANTOIN MACROCRYSTALLINE