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DOSAGE - TABLET;ORAL - 500MG
USFDA APPLICATION NUMBER - 20572
DOSAGE - POWDER;ORAL - 3GM/TEASPOONFUL
USFDA APPLICATION NUMBER - 20573
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sodium Phenylbutyrate 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 Sodium Phenylbutyrate manufacturer or Sodium Phenylbutyrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Phenylbutyrate manufacturer or Sodium Phenylbutyrate supplier.
PharmaCompass also assists you with knowing the Sodium Phenylbutyrate API Price utilized in the formulation of products. Sodium Phenylbutyrate API Price is not always fixed or binding as the Sodium Phenylbutyrate Price is obtained through a variety of data sources. The Sodium Phenylbutyrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sodium Phenyl Butyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Phenyl Butyrate, including repackagers and relabelers. The FDA regulates Sodium Phenyl Butyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Phenyl Butyrate supplier is an individual or a company that provides Sodium Phenyl Butyrate active pharmaceutical ingredient (API) or Sodium Phenyl Butyrate finished formulations upon request. The Sodium Phenyl Butyrate suppliers may include Sodium Phenyl Butyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Phenyl Butyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Phenyl Butyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Phenyl Butyrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Phenyl Butyrate DMFs exist exist since differing nations have different regulations, such as Sodium Phenyl Butyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Phenyl Butyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Phenyl Butyrate USDMF includes data on Sodium Phenyl Butyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Phenyl Butyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate Drug Master File in Japan (Sodium Phenyl Butyrate JDMF) empowers Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate suppliers with JDMF on PharmaCompass.
A Sodium Phenyl Butyrate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Phenyl Butyrate Certificate of Suitability (COS). The purpose of a Sodium Phenyl Butyrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Phenyl Butyrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Phenyl Butyrate to their clients by showing that a Sodium Phenyl Butyrate CEP has been issued for it. The manufacturer submits a Sodium Phenyl Butyrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Phenyl Butyrate CEP holder for the record. Additionally, the data presented in the Sodium Phenyl Butyrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Phenyl Butyrate DMF.
A Sodium Phenyl Butyrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate suppliers with CEP (COS) on PharmaCompass.
A Sodium Phenyl Butyrate written confirmation (Sodium Phenyl Butyrate WC) is an official document issued by a regulatory agency to a Sodium Phenyl Butyrate manufacturer, verifying that the manufacturing facility of a Sodium Phenyl Butyrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Phenyl Butyrate APIs or Sodium Phenyl Butyrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Phenyl Butyrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Phenyl Butyrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Phenyl Butyrate suppliers with NDC on PharmaCompass.
Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate 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 Sodium Phenyl Butyrate GMP manufacturer or Sodium Phenyl Butyrate GMP API supplier for your needs.
A Sodium Phenyl Butyrate CoA (Certificate of Analysis) is a formal document that attests to Sodium Phenyl Butyrate's compliance with Sodium Phenyl Butyrate specifications and serves as a tool for batch-level quality control.
Sodium Phenyl Butyrate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Phenyl Butyrate 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.
Sodium Phenyl Butyrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Phenyl Butyrate EP), Sodium Phenyl Butyrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Phenyl Butyrate USP).
