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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 1-butyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-butyrate, including repackagers and relabelers. The FDA regulates 1-butyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-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 1-butyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1-butyrate supplier is an individual or a company that provides 1-butyrate active pharmaceutical ingredient (API) or 1-butyrate finished formulations upon request. The 1-butyrate suppliers may include 1-butyrate API manufacturers, exporters, distributors and traders.
click here to find a list of 1-butyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1-butyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-butyrate active pharmaceutical ingredient (API) in detail. Different forms of 1-butyrate DMFs exist exist since differing nations have different regulations, such as 1-butyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-butyrate DMF submitted to regulatory agencies in the US is known as a USDMF. 1-butyrate USDMF includes data on 1-butyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-butyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1-butyrate suppliers with USDMF on PharmaCompass.
A 1-butyrate CEP of the European Pharmacopoeia monograph is often referred to as a 1-butyrate Certificate of Suitability (COS). The purpose of a 1-butyrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1-butyrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1-butyrate to their clients by showing that a 1-butyrate CEP has been issued for it. The manufacturer submits a 1-butyrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1-butyrate CEP holder for the record. Additionally, the data presented in the 1-butyrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1-butyrate DMF.
A 1-butyrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1-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 1-butyrate suppliers with CEP (COS) on PharmaCompass.
1-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 1-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 1-butyrate GMP manufacturer or 1-butyrate GMP API supplier for your needs.
A 1-butyrate CoA (Certificate of Analysis) is a formal document that attests to 1-butyrate's compliance with 1-butyrate specifications and serves as a tool for batch-level quality control.
1-butyrate CoA mostly includes findings from lab analyses of a specific batch. For each 1-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.
1-butyrate may be tested according to a variety of international standards, such as European Pharmacopoeia (1-butyrate EP), 1-butyrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-butyrate USP).