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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
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ABOUT THIS PAGE
A Dextrans manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextrans, including repackagers and relabelers. The FDA regulates Dextrans manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextrans 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 Dextrans manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextrans supplier is an individual or a company that provides Dextrans active pharmaceutical ingredient (API) or Dextrans finished formulations upon request. The Dextrans suppliers may include Dextrans API manufacturers, exporters, distributors and traders.
click here to find a list of Dextrans suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dextrans DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextrans active pharmaceutical ingredient (API) in detail. Different forms of Dextrans DMFs exist exist since differing nations have different regulations, such as Dextrans USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dextrans DMF submitted to regulatory agencies in the US is known as a USDMF. Dextrans USDMF includes data on Dextrans's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextrans USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dextrans 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 Dextrans Drug Master File in Japan (Dextrans JDMF) empowers Dextrans 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 Dextrans JDMF during the approval evaluation for pharmaceutical products. At the time of Dextrans 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 Dextrans suppliers with JDMF on PharmaCompass.
A Dextrans CEP of the European Pharmacopoeia monograph is often referred to as a Dextrans Certificate of Suitability (COS). The purpose of a Dextrans CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dextrans EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dextrans to their clients by showing that a Dextrans CEP has been issued for it. The manufacturer submits a Dextrans CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dextrans CEP holder for the record. Additionally, the data presented in the Dextrans CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dextrans DMF.
A Dextrans CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dextrans 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 Dextrans suppliers with CEP (COS) 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 Dextrans as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dextrans 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 Dextrans 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 Dextrans and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dextrans NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dextrans suppliers with NDC on PharmaCompass.
Dextrans 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 Dextrans 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 Dextrans GMP manufacturer or Dextrans GMP API supplier for your needs.
A Dextrans CoA (Certificate of Analysis) is a formal document that attests to Dextrans's compliance with Dextrans specifications and serves as a tool for batch-level quality control.
Dextrans CoA mostly includes findings from lab analyses of a specific batch. For each Dextrans 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.
Dextrans may be tested according to a variety of international standards, such as European Pharmacopoeia (Dextrans EP), Dextrans JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dextrans USP).
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