API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
67
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 dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sodium citrate dihydrate, including repackagers and relabelers. The FDA regulates sodium citrate dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sodium citrate dihydrate 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 dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A sodium citrate dihydrate supplier is an individual or a company that provides sodium citrate dihydrate active pharmaceutical ingredient (API) or sodium citrate dihydrate finished formulations upon request. The sodium citrate dihydrate suppliers may include sodium citrate dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of sodium citrate dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A sodium citrate dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of sodium citrate dihydrate active pharmaceutical ingredient (API) in detail. Different forms of sodium citrate dihydrate DMFs exist exist since differing nations have different regulations, such as sodium citrate dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sodium citrate dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. sodium citrate dihydrate USDMF includes data on sodium citrate dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sodium citrate dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of sodium citrate dihydrate suppliers with USDMF on PharmaCompass.
A sodium citrate dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a sodium citrate dihydrate Certificate of Suitability (COS). The purpose of a sodium citrate dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of sodium citrate dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of sodium citrate dihydrate to their clients by showing that a sodium citrate dihydrate CEP has been issued for it. The manufacturer submits a sodium citrate dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a sodium citrate dihydrate CEP holder for the record. Additionally, the data presented in the sodium citrate dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the sodium citrate dihydrate DMF.
A sodium citrate dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. sodium citrate dihydrate 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 dihydrate suppliers with CEP (COS) on PharmaCompass.
sodium citrate dihydrate 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 dihydrate 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 dihydrate GMP manufacturer or sodium citrate dihydrate GMP API supplier for your needs.
A sodium citrate dihydrate CoA (Certificate of Analysis) is a formal document that attests to sodium citrate dihydrate's compliance with sodium citrate dihydrate specifications and serves as a tool for batch-level quality control.
sodium citrate dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each sodium citrate dihydrate 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 dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (sodium citrate dihydrate EP), sodium citrate dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (sodium citrate dihydrate USP).