Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Australia
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Market Place
ABOUT THIS PAGE
49
PharmaCompass offers a list of Icodextrin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Icodextrin manufacturer or Icodextrin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Icodextrin manufacturer or Icodextrin supplier.
A Extraneal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Extraneal, including repackagers and relabelers. The FDA regulates Extraneal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Extraneal 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 Extraneal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Extraneal supplier is an individual or a company that provides Extraneal active pharmaceutical ingredient (API) or Extraneal finished formulations upon request. The Extraneal suppliers may include Extraneal API manufacturers, exporters, distributors and traders.
click here to find a list of Extraneal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Extraneal DMF (Drug Master File) is a document detailing the whole manufacturing process of Extraneal active pharmaceutical ingredient (API) in detail. Different forms of Extraneal DMFs exist exist since differing nations have different regulations, such as Extraneal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Extraneal DMF submitted to regulatory agencies in the US is known as a USDMF. Extraneal USDMF includes data on Extraneal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Extraneal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Extraneal suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Extraneal Drug Master File in Korea (Extraneal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Extraneal. The MFDS reviews the Extraneal KDMF as part of the drug registration process and uses the information provided in the Extraneal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Extraneal KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Extraneal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Extraneal suppliers with KDMF 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 Extraneal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Extraneal 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 Extraneal 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 Extraneal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Extraneal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Extraneal suppliers with NDC on PharmaCompass.
Extraneal 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 Extraneal GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Extraneal GMP manufacturer or Extraneal GMP API supplier for your needs.
A Extraneal CoA (Certificate of Analysis) is a formal document that attests to Extraneal's compliance with Extraneal specifications and serves as a tool for batch-level quality control.
Extraneal CoA mostly includes findings from lab analyses of a specific batch. For each Extraneal 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.
Extraneal may be tested according to a variety of international standards, such as European Pharmacopoeia (Extraneal EP), Extraneal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Extraneal USP).
