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