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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 2025
Registration Country : Poland
Brand Name :
Dosage Form : Powder for Solution fo...
Dosage Strength : 40MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q2 2025
Registration Country : Poland
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23 Jun 2020
// K. Blankenship FIERCE PHARMA
21 Jun 2020
// BIOSPACE
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// EMA
02 Mar 2020
// PRESS RELEASE
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PharmaCompass offers a list of Fosfomycin Sodium 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 Sodium manufacturer or Fosfomycin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fosfomycin Sodium manufacturer or Fosfomycin Sodium supplier.
PharmaCompass also assists you with knowing the Fosfomycin Sodium API Price utilized in the formulation of products. Fosfomycin Sodium API Price is not always fixed or binding as the Fosfomycin Sodium Price is obtained through a variety of data sources. The Fosfomycin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fosfomycin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosfomycin Sodium, including repackagers and relabelers. The FDA regulates Fosfomycin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosfomycin Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosfomycin Sodium supplier is an individual or a company that provides Fosfomycin Sodium active pharmaceutical ingredient (API) or Fosfomycin Sodium finished formulations upon request. The Fosfomycin Sodium suppliers may include Fosfomycin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Fosfomycin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosfomycin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosfomycin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Fosfomycin Sodium DMFs exist exist since differing nations have different regulations, such as Fosfomycin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosfomycin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fosfomycin Sodium USDMF includes data on Fosfomycin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosfomycin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosfomycin Sodium 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 Sodium Drug Master File in Japan (Fosfomycin Sodium JDMF) empowers Fosfomycin Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Fosfomycin Sodium 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 Sodium suppliers with JDMF 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 Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fosfomycin Sodium 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 Sodium 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 Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fosfomycin Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fosfomycin Sodium suppliers with NDC on PharmaCompass.
Fosfomycin Sodium 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 Sodium 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 Sodium GMP manufacturer or Fosfomycin Sodium GMP API supplier for your needs.
A Fosfomycin Sodium CoA (Certificate of Analysis) is a formal document that attests to Fosfomycin Sodium's compliance with Fosfomycin Sodium specifications and serves as a tool for batch-level quality control.
Fosfomycin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Fosfomycin Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Fosfomycin Sodium EP), Fosfomycin Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fosfomycin Sodium USP).
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