01 1Roquette
01 1ROQUETTE® POLYDEXTRIN (Icodextrin)
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37662
Submission : 2022-12-20
Status : Active
Type : II
23
PharmaCompass offers a list of Polydextrose 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 Polydextrose manufacturer or Polydextrose supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polydextrose manufacturer or Polydextrose supplier.
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, and COA 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, and COA 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.
