Nitrofurantoin Monohydrate | 16620 | CAPSULE;ORAL | 25MG

Nitrofurantoin, Monohydrate

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ACTIVE PHARMA INGREDIENTS

55 API Suppliers, 34 USDMF, 16 CEP/COS, 7 EU WC, 28 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

129 FDF Dossiers, 70 FDA Orange Book, 22 Europe, 6 Canada, 4 Australia, 8 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

5 Rochem International Inc, 7 SPI Pharma, 10 DKSH, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 1 Bioplus Life Sciences, 15 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 6 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 15 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 8 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, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 37 Direct Compression, 35 Thickeners and Stabilizers, 32 Controlled & Modified Release, 23 Granulation, 21 Taste Masking, 19 Film Formers & Plasticizers, 19 Solubilizers, 17 Co-Processed Excipients, 16 Lubricants & Glidants, 13 Disintegrants & Superdisintegrants, 11 Topical, 10 Parenteral, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 6 Rheology Modifiers, 5 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

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GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 17 Finished Drug Prices

MARKET PLACE

27 APIs, 10 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 USP, 3 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 16620 / DOSAGE - CAPSULE;ORAL - 25MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NITROFURANTOIN(UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)	NITROFURANTOIN	50mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	American Health Packaging	BluePoint Laboratories	Bryant Ranch Prepack	Lake Erie Medical DBA Quality Care Products LLC	NuCare Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NuCare Pharmaceuticals Industries, Inc.	REMEDYREPACK INC.
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C YELLOW NO. 6(H77VEI93A8)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Nitrofurantoin Monohydrate