01 1Toray Industries
01 1NALFURAFINE (TRK-820) DRUG SUBSTANCE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18927
Submission : 2005-10-31
Status : Active
Type : II
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PharmaCompass offers a list of Nalfurafine 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 Nalfurafine manufacturer or Nalfurafine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nalfurafine manufacturer or Nalfurafine supplier.
A Nalfurafine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalfurafine, including repackagers and relabelers. The FDA regulates Nalfurafine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalfurafine 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 Nalfurafine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nalfurafine supplier is an individual or a company that provides Nalfurafine active pharmaceutical ingredient (API) or Nalfurafine finished formulations upon request. The Nalfurafine suppliers may include Nalfurafine API manufacturers, exporters, distributors and traders.
click here to find a list of Nalfurafine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nalfurafine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nalfurafine active pharmaceutical ingredient (API) in detail. Different forms of Nalfurafine DMFs exist exist since differing nations have different regulations, such as Nalfurafine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nalfurafine DMF submitted to regulatory agencies in the US is known as a USDMF. Nalfurafine USDMF includes data on Nalfurafine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nalfurafine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nalfurafine suppliers with USDMF on PharmaCompass.
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