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PharmaCompass offers a list of Sodium Butyrate 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 Butyrate manufacturer or Sodium Butyrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Butyrate manufacturer or Sodium Butyrate supplier.
PharmaCompass also assists you with knowing the Sodium Butyrate API Price utilized in the formulation of products. Sodium Butyrate API Price is not always fixed or binding as the Sodium Butyrate Price is obtained through a variety of data sources. The Sodium Butyrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sodium Butyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Butyrate, including repackagers and relabelers. The FDA regulates Sodium Butyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium 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 Butyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Butyrate supplier is an individual or a company that provides Sodium Butyrate active pharmaceutical ingredient (API) or Sodium Butyrate finished formulations upon request. The Sodium Butyrate suppliers may include Sodium Butyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Butyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Butyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Butyrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Butyrate DMFs exist exist since differing nations have different regulations, such as Sodium Butyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Butyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Butyrate USDMF includes data on Sodium Butyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Butyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Butyrate suppliers with USDMF on PharmaCompass.
A Sodium Butyrate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Butyrate Certificate of Suitability (COS). The purpose of a Sodium Butyrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Butyrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Butyrate to their clients by showing that a Sodium Butyrate CEP has been issued for it. The manufacturer submits a Sodium Butyrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Butyrate CEP holder for the record. Additionally, the data presented in the Sodium Butyrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Butyrate DMF.
A Sodium Butyrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium 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 Butyrate suppliers with CEP (COS) on PharmaCompass.
Sodium 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 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 Butyrate GMP manufacturer or Sodium Butyrate GMP API supplier for your needs.
A Sodium Butyrate CoA (Certificate of Analysis) is a formal document that attests to Sodium Butyrate's compliance with Sodium Butyrate specifications and serves as a tool for batch-level quality control.
Sodium Butyrate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium 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 Butyrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Butyrate EP), Sodium Butyrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Butyrate USP).