01 1ABX Advanced Biochemical Compounds
01 1MIBG DRUG SUBSTANCE
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21543
Submission : 2008-04-18
Status : Active
Type : II
A Iobenguane (sulfate) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iobenguane (sulfate), including repackagers and relabelers. The FDA regulates Iobenguane (sulfate) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iobenguane (sulfate) 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 Iobenguane (sulfate) supplier is an individual or a company that provides Iobenguane (sulfate) active pharmaceutical ingredient (API) or Iobenguane (sulfate) finished formulations upon request. The Iobenguane (sulfate) suppliers may include Iobenguane (sulfate) API manufacturers, exporters, distributors and traders.
click here to find a list of Iobenguane (sulfate) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iobenguane (sulfate) DMF (Drug Master File) is a document detailing the whole manufacturing process of Iobenguane (sulfate) active pharmaceutical ingredient (API) in detail. Different forms of Iobenguane (sulfate) DMFs exist exist since differing nations have different regulations, such as Iobenguane (sulfate) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iobenguane (sulfate) DMF submitted to regulatory agencies in the US is known as a USDMF. Iobenguane (sulfate) USDMF includes data on Iobenguane (sulfate)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iobenguane (sulfate) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iobenguane (sulfate) suppliers with USDMF on PharmaCompass.
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