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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Polydextrose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polydextrose, including repackagers and relabelers. The FDA regulates Polydextrose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polydextrose 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 Polydextrose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polydextrose supplier is an individual or a company that provides Polydextrose active pharmaceutical ingredient (API) or Polydextrose finished formulations upon request. The Polydextrose suppliers may include Polydextrose API manufacturers, exporters, distributors and traders.
click here to find a list of Polydextrose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polydextrose DMF (Drug Master File) is a document detailing the whole manufacturing process of Polydextrose active pharmaceutical ingredient (API) in detail. Different forms of Polydextrose DMFs exist exist since differing nations have different regulations, such as Polydextrose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polydextrose DMF submitted to regulatory agencies in the US is known as a USDMF. Polydextrose USDMF includes data on Polydextrose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polydextrose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polydextrose 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 Polydextrose Drug Master File in Japan (Polydextrose JDMF) empowers Polydextrose 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 Polydextrose JDMF during the approval evaluation for pharmaceutical products. At the time of Polydextrose 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 Polydextrose suppliers with JDMF on PharmaCompass.
Polydextrose 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 Polydextrose 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 Polydextrose GMP manufacturer or Polydextrose GMP API supplier for your needs.
A Polydextrose CoA (Certificate of Analysis) is a formal document that attests to Polydextrose's compliance with Polydextrose specifications and serves as a tool for batch-level quality control.
Polydextrose CoA mostly includes findings from lab analyses of a specific batch. For each Polydextrose 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.
Polydextrose may be tested according to a variety of international standards, such as European Pharmacopoeia (Polydextrose EP), Polydextrose JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polydextrose USP).
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