01 1Procos
01 1CHLOPHEDIANOL HYDROCHLORIDE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22902
Submission : 2009-06-25
Status : Active
Type : II
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A Refugal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Refugal, including repackagers and relabelers. The FDA regulates Refugal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Refugal 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 Refugal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Refugal supplier is an individual or a company that provides Refugal active pharmaceutical ingredient (API) or Refugal finished formulations upon request. The Refugal suppliers may include Refugal API manufacturers, exporters, distributors and traders.
click here to find a list of Refugal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Refugal DMF (Drug Master File) is a document detailing the whole manufacturing process of Refugal active pharmaceutical ingredient (API) in detail. Different forms of Refugal DMFs exist exist since differing nations have different regulations, such as Refugal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Refugal DMF submitted to regulatory agencies in the US is known as a USDMF. Refugal USDMF includes data on Refugal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Refugal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Refugal suppliers with USDMF on PharmaCompass.
