01 1Dupont
01 1COBALT-57
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1577
Submission : 1970-10-08
Status : Inactive
Type : II
A Cobalt-57 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cobalt-57, including repackagers and relabelers. The FDA regulates Cobalt-57 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cobalt-57 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 Cobalt-57 supplier is an individual or a company that provides Cobalt-57 active pharmaceutical ingredient (API) or Cobalt-57 finished formulations upon request. The Cobalt-57 suppliers may include Cobalt-57 API manufacturers, exporters, distributors and traders.
click here to find a list of Cobalt-57 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cobalt-57 DMF (Drug Master File) is a document detailing the whole manufacturing process of Cobalt-57 active pharmaceutical ingredient (API) in detail. Different forms of Cobalt-57 DMFs exist exist since differing nations have different regulations, such as Cobalt-57 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cobalt-57 DMF submitted to regulatory agencies in the US is known as a USDMF. Cobalt-57 USDMF includes data on Cobalt-57's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cobalt-57 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cobalt-57 suppliers with USDMF on PharmaCompass.
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