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