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Nitrofurantoin, Monohydrate

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 download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
31/10/2025	ASolution Pharmaceuticals	India	ASOLUTION PHARMACEUTICALS PVT LTD	38079	NITROFURANTOIN MONOHYDRATE	2023-05-10	Active	II	N/A
31/10/2025	Mankind Pharma	India	MANKIND PHARMA LTD	33351	NITROFURANTOIN MONOHYDRATE USP	2018-12-28	Active	II	Complete	2019-04-26	2019-03-05

Nitrofurantoin, Monohydrate

Nitrofurantoin, Monohydrate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

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

INTERMEDIATES

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