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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q2 2024
Registration Country : Poland
Brand Name :
Dosage Form : Granulate Powder for S...
Dosage Strength : 3000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q2 2024
Registration Country : Poland
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Fosfomycin Trometamol
Dosage Form : DC Granules
Dosage Strength : 3G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Fosfomycin Trometamol
Dosage Form : Granules for Oral Solu...
Dosage Strength : 3G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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PharmaCompass offers a list of Fosfomycin 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 Fosfomycin manufacturer or Fosfomycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fosfomycin manufacturer or Fosfomycin supplier.
PharmaCompass also assists you with knowing the Fosfomycin API Price utilized in the formulation of products. Fosfomycin API Price is not always fixed or binding as the Fosfomycin Price is obtained through a variety of data sources. The Fosfomycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fosfomycin Trometamol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosfomycin Trometamol, including repackagers and relabelers. The FDA regulates Fosfomycin Trometamol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosfomycin Trometamol 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 Fosfomycin Trometamol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosfomycin Trometamol supplier is an individual or a company that provides Fosfomycin Trometamol active pharmaceutical ingredient (API) or Fosfomycin Trometamol finished formulations upon request. The Fosfomycin Trometamol suppliers may include Fosfomycin Trometamol API manufacturers, exporters, distributors and traders.
click here to find a list of Fosfomycin Trometamol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosfomycin Trometamol DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosfomycin Trometamol active pharmaceutical ingredient (API) in detail. Different forms of Fosfomycin Trometamol DMFs exist exist since differing nations have different regulations, such as Fosfomycin Trometamol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosfomycin Trometamol DMF submitted to regulatory agencies in the US is known as a USDMF. Fosfomycin Trometamol USDMF includes data on Fosfomycin Trometamol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosfomycin Trometamol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosfomycin Trometamol suppliers with USDMF on PharmaCompass.
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 Fosfomycin Trometamol Drug Master File in Japan (Fosfomycin Trometamol JDMF) empowers Fosfomycin Trometamol 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 Fosfomycin Trometamol JDMF during the approval evaluation for pharmaceutical products. At the time of Fosfomycin Trometamol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Fosfomycin Trometamol suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Fosfomycin Trometamol Drug Master File in Korea (Fosfomycin Trometamol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fosfomycin Trometamol. The MFDS reviews the Fosfomycin Trometamol KDMF as part of the drug registration process and uses the information provided in the Fosfomycin Trometamol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fosfomycin Trometamol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Fosfomycin Trometamol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fosfomycin Trometamol suppliers with KDMF on PharmaCompass.
A Fosfomycin Trometamol CEP of the European Pharmacopoeia monograph is often referred to as a Fosfomycin Trometamol Certificate of Suitability (COS). The purpose of a Fosfomycin Trometamol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fosfomycin Trometamol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fosfomycin Trometamol to their clients by showing that a Fosfomycin Trometamol CEP has been issued for it. The manufacturer submits a Fosfomycin Trometamol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fosfomycin Trometamol CEP holder for the record. Additionally, the data presented in the Fosfomycin Trometamol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fosfomycin Trometamol DMF.
A Fosfomycin Trometamol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fosfomycin Trometamol 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 Fosfomycin Trometamol suppliers with CEP (COS) on PharmaCompass.
A Fosfomycin Trometamol written confirmation (Fosfomycin Trometamol WC) is an official document issued by a regulatory agency to a Fosfomycin Trometamol manufacturer, verifying that the manufacturing facility of a Fosfomycin Trometamol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fosfomycin Trometamol APIs or Fosfomycin Trometamol finished pharmaceutical products to another nation, regulatory agencies frequently require a Fosfomycin Trometamol WC (written confirmation) as part of the regulatory process.
click here to find a list of Fosfomycin Trometamol 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 Fosfomycin Trometamol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fosfomycin Trometamol 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 Fosfomycin Trometamol 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 Fosfomycin Trometamol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fosfomycin Trometamol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fosfomycin Trometamol suppliers with NDC on PharmaCompass.
Fosfomycin Trometamol 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 Fosfomycin Trometamol 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 Fosfomycin Trometamol GMP manufacturer or Fosfomycin Trometamol GMP API supplier for your needs.
A Fosfomycin Trometamol CoA (Certificate of Analysis) is a formal document that attests to Fosfomycin Trometamol's compliance with Fosfomycin Trometamol specifications and serves as a tool for batch-level quality control.
Fosfomycin Trometamol CoA mostly includes findings from lab analyses of a specific batch. For each Fosfomycin Trometamol 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.
Fosfomycin Trometamol may be tested according to a variety of international standards, such as European Pharmacopoeia (Fosfomycin Trometamol EP), Fosfomycin Trometamol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fosfomycin Trometamol USP).
