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List of Drug Master Files (DMF) of Nitrofurantoin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ASolution Pharmaceuticals (2)

02 Fermion Oy (2)

03 Actavis Inc (2)

04 Alembic Pharmaceuticals Limited (2)

05 Assia Chemical Industries Ltd (1)

06 Cambrex Corporation (2)

07 F.I.S. Fabbrica Italiana Sintetici (3)

08 Jinan Jinda Pharmaceutical Chemistry Co Ltd (3)

09 Lek Pharmaceuticals (1)

10 Macleods Pharmaceuticals Limited (2)

11 Maithri Drugs (3)

12 Mankind Pharma (2)

13 Omsav Pharma Research (2)

14 PCA - Prodotti Chimicie Alimentari S.p.A (1)

15 Roche Diagnostics GmbH (1)

16 Sandoz B2B (1)

17 Unimark Remedies Limited (4)

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01 FDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY MONOTHERAPY CLINICAL TRIALS (1)

02 MANUFACTURE OF NITROFURANTOIN (1)

03 NITROFURANTOIN (2)

04 NITROFURANTOIN MONOHYDRATE USP (1)

05 NITROFURANTOIN & NITROFURANTOIN MACROCRYSTALS (1)

06 NITROFURANTOIN ANHYDROUS (1)

07 NITROFURANTOIN ANHYDROUS (MACROCRYSTAL) (1)

08 NITROFURANTOIN ANHYDROUS CRYSTALS USP (1)

09 NITROFURANTOIN ANHYDROUS USP (2)

10 NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS) (2)

11 NITROFURANTOIN HYDROUS USP (1)

12 NITROFURANTOIN MACROCRYSTAL (1)

13 NITROFURANTOIN MACROCRYSTAL USP (1)

14 NITROFURANTOIN MACROCRYSTALLINE (1)

15 NITROFURANTOIN MACROCRYSTALS (2)

16 NITROFURANTOIN MACROCRYSTALS USP (3)

17 NITROFURANTOIN MONOHYDRATE (6)

18 NITROFURANTOIN MONOHYDRATE (CODE 1042-1026) (1)

19 NITROFURANTOIN MONOHYDRATE USP (4)

20 NITROFURANTOIN U.S.P (1)

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01 China (3)

02 Finland (2)

03 Germany (1)

04 India (17)

05 Ireland (2)

06 Israel (1)

07 Italy (4)

08 Slovenia (1)

09 Switzerland (1)

10 U.S.A (2)

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01 Active (26)

02 Inactive (8)

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01 Complete (16)

02 Blank (18)

URL Supplier Web Content
15504
Active
2001-07-11
N/A
II
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16505
Active
2003-04-22
N/A
II
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13266
Active
1998-10-05
Complete
2013-01-11
2012-12-10
II
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453
Active
1965-07-13
Complete
2013-01-18
2012-12-21
II
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21887
Active
2008-08-05
Complete
2015-01-08
2014-12-18
II
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23500
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2010-02-16
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Looking for 67-20-9 / Nitrofurantoin API manufacturers, exporters & distributors?

Nitrofurantoin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Nitrofurantoin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nitrofurantoin manufacturer or Nitrofurantoin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nitrofurantoin manufacturer or Nitrofurantoin supplier.

PharmaCompass also assists you with knowing the Nitrofurantoin API Price utilized in the formulation of products. Nitrofurantoin API Price is not always fixed or binding as the Nitrofurantoin Price is obtained through a variety of data sources. The Nitrofurantoin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Nitrofurantoin

Synonyms

67-20-9, Macrodantin, Furadantin, 5-nitrofurantoin, Furadonine, Furadantine

Cas Number

67-20-9

Unique Ingredient Identifier (UNII)

927AH8112L

About Nitrofurantoin

A urinary anti-infective agent effective against most gram-positive and gram-negative organisms. Although sulfonamides and antibiotics are usually the agents of choice for urinary tract infections, nitrofurantoin is widely used for prophylaxis and long-term suppression.

Nitrofurantoin Manufacturers

A Nitrofurantoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrofurantoin, including repackagers and relabelers. The FDA regulates Nitrofurantoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrofurantoin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Nitrofurantoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Nitrofurantoin Suppliers

A Nitrofurantoin supplier is an individual or a company that provides Nitrofurantoin active pharmaceutical ingredient (API) or Nitrofurantoin finished formulations upon request. The Nitrofurantoin suppliers may include Nitrofurantoin API manufacturers, exporters, distributors and traders.

click here to find a list of Nitrofurantoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Nitrofurantoin USDMF

A Nitrofurantoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitrofurantoin active pharmaceutical ingredient (API) in detail. Different forms of Nitrofurantoin DMFs exist exist since differing nations have different regulations, such as Nitrofurantoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Nitrofurantoin DMF submitted to regulatory agencies in the US is known as a USDMF. Nitrofurantoin USDMF includes data on Nitrofurantoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitrofurantoin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Nitrofurantoin suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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