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PharmaCompass offers a list of Norfloxacin 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 Norfloxacin manufacturer or Norfloxacin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Norfloxacin manufacturer or Norfloxacin supplier.
PharmaCompass also assists you with knowing the Norfloxacin API Price utilized in the formulation of products. Norfloxacin API Price is not always fixed or binding as the Norfloxacin Price is obtained through a variety of data sources. The Norfloxacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid, including repackagers and relabelers. The FDA regulates 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid 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 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid supplier is an individual or a company that provides 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid active pharmaceutical ingredient (API) or 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid finished formulations upon request. The 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid suppliers may include 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid API manufacturers, exporters, distributors and traders.
click here to find a list of 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid active pharmaceutical ingredient (API) in detail. Different forms of 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid DMFs exist exist since differing nations have different regulations, such as 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid DMF submitted to regulatory agencies in the US is known as a USDMF. 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid USDMF includes data on 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid Drug Master File in Japan (1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid JDMF) empowers 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid JDMF during the approval evaluation for pharmaceutical products. At the time of 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEP of the European Pharmacopoeia monograph is often referred to as a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid Certificate of Suitability (COS). The purpose of a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid to their clients by showing that a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEP has been issued for it. The manufacturer submits a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEP holder for the record. Additionally, the data presented in the 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid DMF.
A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid written confirmation (1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid WC) is an official document issued by a regulatory agency to a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid manufacturer, verifying that the manufacturing facility of a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid APIs or 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid finished pharmaceutical products to another nation, regulatory agencies frequently require a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid WC (written confirmation) as part of the regulatory process.
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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 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid 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 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid 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 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid NDC to their finished compounded human drug products, they may choose to do so.
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1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid 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 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid 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 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid GMP manufacturer or 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid GMP API supplier for your needs.
A 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CoA (Certificate of Analysis) is a formal document that attests to 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid's compliance with 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid specifications and serves as a tool for batch-level quality control.
1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid CoA mostly includes findings from lab analyses of a specific batch. For each 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid 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.
1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid may be tested according to a variety of international standards, such as European Pharmacopoeia (1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid EP), 1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-ethyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid USP).