01 1MDS NORDION
01 1ALTROPANE(R) [123I]-E-IACFT INJECTION
01 1Canada
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16421
Submission : 2003-01-10
Status : Inactive
Type : II
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A Altropane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Altropane, including repackagers and relabelers. The FDA regulates Altropane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Altropane 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 Altropane supplier is an individual or a company that provides Altropane active pharmaceutical ingredient (API) or Altropane finished formulations upon request. The Altropane suppliers may include Altropane API manufacturers, exporters, distributors and traders.
click here to find a list of Altropane suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Altropane DMF (Drug Master File) is a document detailing the whole manufacturing process of Altropane active pharmaceutical ingredient (API) in detail. Different forms of Altropane DMFs exist exist since differing nations have different regulations, such as Altropane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Altropane DMF submitted to regulatory agencies in the US is known as a USDMF. Altropane USDMF includes data on Altropane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Altropane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Altropane suppliers with USDMF on PharmaCompass.
