API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
62
PharmaCompass offers a list of Trisodium Citrate Dihydrate 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 Trisodium Citrate Dihydrate manufacturer or Trisodium Citrate Dihydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trisodium Citrate Dihydrate manufacturer or Trisodium Citrate Dihydrate supplier.
PharmaCompass also assists you with knowing the Trisodium Citrate Dihydrate API Price utilized in the formulation of products. Trisodium Citrate Dihydrate API Price is not always fixed or binding as the Trisodium Citrate Dihydrate Price is obtained through a variety of data sources. The Trisodium Citrate Dihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate;, including repackagers and relabelers. The FDA regulates 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; supplier is an individual or a company that provides 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; active pharmaceutical ingredient (API) or 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; finished formulations upon request. The 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; suppliers may include 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; API manufacturers, exporters, distributors and traders.
click here to find a list of 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; active pharmaceutical ingredient (API) in detail. Different forms of 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; DMFs exist exist since differing nations have different regulations, such as 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; DMF submitted to regulatory agencies in the US is known as a USDMF. 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; USDMF includes data on 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate;'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; 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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; Drug Master File in Japan (1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; JDMF) empowers 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; 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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; JDMF during the approval evaluation for pharmaceutical products. At the time of 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; 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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; suppliers with JDMF 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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; 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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; 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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; suppliers with NDC on PharmaCompass.
1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;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 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; GMP manufacturer or 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; GMP API supplier for your needs.
A 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; CoA (Certificate of Analysis) is a formal document that attests to 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate;'s compliance with 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; specifications and serves as a tool for batch-level quality control.
1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; CoA mostly includes findings from lab analyses of a specific batch. For each 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;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.
1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; may be tested according to a variety of international standards, such as European Pharmacopoeia (1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; EP), 1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1,2,3-Propanetricarboxylicacid, 2-hydroxy-, trisodium salt, dihydrate (9CI);Citric acid, trisodium salt,dihydrate (8CI);N 1560;Sodium citrate dihydrate; USP).