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TAPI offers customized CDMO Solutions for API development and manufacturing services.
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
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Certificate Number : R0-CEP 2019-206 - Rev 02
Status : Valid
Issue Date : 2023-03-16
Type : Chemical
Substance Number : 101
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Drugs in Development
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DOSAGE - CAPSULE;ORAL - 100MG
USFDA APPLICATION NUMBER - 16620
DOSAGE - CAPSULE;ORAL - 25MG
USFDA APPLICATION NUMBER - 16620
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 16620
DOSAGE - CAPSULE;ORAL - 75MG;25MG
USFDA APPLICATION NUMBER - 20064
DOSAGE - SUSPENSION;ORAL - 25MG/5ML
USFDA APPLICATION NUMBER - 9175
DOSAGE - SUSPENSION;ORAL - 50MG/5ML
USFDA APPLICATION NUMBER - 9175
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
ABOUT THIS PAGE
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.
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.
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.
A Nitrofurantoin CEP of the European Pharmacopoeia monograph is often referred to as a Nitrofurantoin Certificate of Suitability (COS). The purpose of a Nitrofurantoin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitrofurantoin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitrofurantoin to their clients by showing that a Nitrofurantoin CEP has been issued for it. The manufacturer submits a Nitrofurantoin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitrofurantoin CEP holder for the record. Additionally, the data presented in the Nitrofurantoin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitrofurantoin DMF.
A Nitrofurantoin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitrofurantoin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Nitrofurantoin suppliers with CEP (COS) on PharmaCompass.
A Nitrofurantoin written confirmation (Nitrofurantoin WC) is an official document issued by a regulatory agency to a Nitrofurantoin manufacturer, verifying that the manufacturing facility of a Nitrofurantoin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nitrofurantoin APIs or Nitrofurantoin finished pharmaceutical products to another nation, regulatory agencies frequently require a Nitrofurantoin WC (written confirmation) as part of the regulatory process.
click here to find a list of Nitrofurantoin suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nitrofurantoin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nitrofurantoin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Nitrofurantoin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Nitrofurantoin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nitrofurantoin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nitrofurantoin suppliers with NDC on PharmaCompass.
Nitrofurantoin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Nitrofurantoin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Nitrofurantoin GMP manufacturer or Nitrofurantoin GMP API supplier for your needs.
A Nitrofurantoin CoA (Certificate of Analysis) is a formal document that attests to Nitrofurantoin's compliance with Nitrofurantoin specifications and serves as a tool for batch-level quality control.
Nitrofurantoin CoA mostly includes findings from lab analyses of a specific batch. For each Nitrofurantoin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Nitrofurantoin may be tested according to a variety of international standards, such as European Pharmacopoeia (Nitrofurantoin EP), Nitrofurantoin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nitrofurantoin USP).
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