Nitrofurantoin Monohydrate | 16620 | CAPSULE;ORAL | 50MG

Nitrofurantoin, Monohydrate

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ACTIVE PHARMA INGREDIENTS

53 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 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

131 FDF Dossiers, 72 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, 7 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 5 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 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 36 Direct Compression, 35 Thickeners and Stabilizers, 32 Controlled & Modified Release, 23 Granulation, 21 Taste Masking, 19 Film Formers & Plasticizers, 18 Solubilizers, 17 Co-Processed Excipients, 16 Lubricants & Glidants, 12 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 - 50MG

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 LLC	Bryant Ranch Prepack	NCS HealthCare of KY, Inc dba Vangard Labs	Teva Pharmaceuticals USA, Inc.	A-S Medication Solutions	American Health Packaging	BluePoint Laboratories	Lake Erie Medical DBA Quality Care Products LLC	Mylan Institutional Inc.	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	REMEDYREPACK INC.	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NuCare Pharmaceuticals Industries, Inc.
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS LACTOSE(3SY5LH9PMK)
BUTYL ALCOHOL(8PJ61P6TS3)
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10(35SW5USQ3G)
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)
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