01 1Bayer AG
01 1BAY 1903149 (THORIUM-227 CHLORIDE)
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31637
Submission : 2017-05-25
Status : Inactive
Type : II
A Radium-224 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Radium-224, including repackagers and relabelers. The FDA regulates Radium-224 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Radium-224 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 Radium-224 supplier is an individual or a company that provides Radium-224 active pharmaceutical ingredient (API) or Radium-224 finished formulations upon request. The Radium-224 suppliers may include Radium-224 API manufacturers, exporters, distributors and traders.
click here to find a list of Radium-224 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Radium-224 DMF (Drug Master File) is a document detailing the whole manufacturing process of Radium-224 active pharmaceutical ingredient (API) in detail. Different forms of Radium-224 DMFs exist exist since differing nations have different regulations, such as Radium-224 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Radium-224 DMF submitted to regulatory agencies in the US is known as a USDMF. Radium-224 USDMF includes data on Radium-224's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Radium-224 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Radium-224 suppliers with USDMF on PharmaCompass.
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