01 1GE Healthcare Inc
01 1INDIUM III OXINE (DMF FORMERLY HELD BY DIAGNOSTIC ISOTOPES INC)
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2867
Submission : 1977-03-07
Status : Inactive
Type : II
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A Indium In 111 Oxyquinoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indium In 111 Oxyquinoline, including repackagers and relabelers. The FDA regulates Indium In 111 Oxyquinoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indium In 111 Oxyquinoline 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 Indium In 111 Oxyquinoline supplier is an individual or a company that provides Indium In 111 Oxyquinoline active pharmaceutical ingredient (API) or Indium In 111 Oxyquinoline finished formulations upon request. The Indium In 111 Oxyquinoline suppliers may include Indium In 111 Oxyquinoline API manufacturers, exporters, distributors and traders.
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A Indium In 111 Oxyquinoline DMF (Drug Master File) is a document detailing the whole manufacturing process of Indium In 111 Oxyquinoline active pharmaceutical ingredient (API) in detail. Different forms of Indium In 111 Oxyquinoline DMFs exist exist since differing nations have different regulations, such as Indium In 111 Oxyquinoline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indium In 111 Oxyquinoline DMF submitted to regulatory agencies in the US is known as a USDMF. Indium In 111 Oxyquinoline USDMF includes data on Indium In 111 Oxyquinoline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indium In 111 Oxyquinoline USDMF is kept confidential to protect the manufacturer’s intellectual property.
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