Nitrofurantoin Monohydrate | 16620 | CAPSULE;ORAL | 100MG

Nitrofurantoin, Monohydrate

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 34 USDMF, 16 CEP/COS, 7 EU WC, 28 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

130 FDF Dossiers, 71 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 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 4 Vegetarian Capsules, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

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2 DATA COMPILATION #PharmaFlow, 29 NEWS #PharmaBuzz

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 - 100MG

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

Inactive Ingredients

Ingredient Name	REMEDYREPACK INC.	American Health Packaging	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Liberty Pharmaceuticals, Inc.	NuCare Pharmaceuticals,Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	Lake Erie Medical DBA Quality Care Products LLC	PD-Rx Pharmaceuticals, Inc.	Teva Pharmaceuticals USA, Inc.	Unit Dose Services	A-S Medication Solutions	A-S Medication Solutions LLC	BluePoint Laboratories	Bryant Ranch Prepack	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Mylan Institutional Inc.	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	NuCare Pharmaceuticals Industries, Inc.
ALGINIC ACID(8C3Z4148WZ)
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYL ALCOHOL(8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10(35SW5USQ3G)
DIPROPYLENE GLYCOL(E107L85C40)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDRATED SILICA(Y6O7T4G8P9)
HYPROMELLOSES(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Nitrofurantoin Monohydrate