01 1ISO TEX DIAGNOSTICS INC
01 1INDIUM-111
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13152
Submission : 1998-08-25
Status : Inactive
Type : II
A Indium-111 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indium-111, including repackagers and relabelers. The FDA regulates Indium-111 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indium-111 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-111 supplier is an individual or a company that provides Indium-111 active pharmaceutical ingredient (API) or Indium-111 finished formulations upon request. The Indium-111 suppliers may include Indium-111 API manufacturers, exporters, distributors and traders.
click here to find a list of Indium-111 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indium-111 DMF (Drug Master File) is a document detailing the whole manufacturing process of Indium-111 active pharmaceutical ingredient (API) in detail. Different forms of Indium-111 DMFs exist exist since differing nations have different regulations, such as Indium-111 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indium-111 DMF submitted to regulatory agencies in the US is known as a USDMF. Indium-111 USDMF includes data on Indium-111's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indium-111 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indium-111 suppliers with USDMF on PharmaCompass.
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