01 1Kissei Pharmaceutical
01 1KUR-1246 DRUG SUBSTANCE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17734
Submission : 2004-10-07
Status : Active
Type : II
A Bedoradrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bedoradrine, including repackagers and relabelers. The FDA regulates Bedoradrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bedoradrine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Bedoradrine supplier is an individual or a company that provides Bedoradrine active pharmaceutical ingredient (API) or Bedoradrine finished formulations upon request. The Bedoradrine suppliers may include Bedoradrine API manufacturers, exporters, distributors and traders.
click here to find a list of Bedoradrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bedoradrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Bedoradrine active pharmaceutical ingredient (API) in detail. Different forms of Bedoradrine DMFs exist exist since differing nations have different regulations, such as Bedoradrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bedoradrine DMF submitted to regulatory agencies in the US is known as a USDMF. Bedoradrine USDMF includes data on Bedoradrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bedoradrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bedoradrine suppliers with USDMF on PharmaCompass.
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