01 1BWX Technologies
02 1CURIUM US LLC
01 1GERMANIUM 68 ULTRA
02 1GERMANIUM-68 CHLORIDE
01 1Canada
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37071
Submission : 2022-08-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33988
Submission : 2020-04-17
Status : Active
Type : II
A Germanium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Germanium, including repackagers and relabelers. The FDA regulates Germanium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Germanium 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 Germanium supplier is an individual or a company that provides Germanium active pharmaceutical ingredient (API) or Germanium finished formulations upon request. The Germanium suppliers may include Germanium API manufacturers, exporters, distributors and traders.
click here to find a list of Germanium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Germanium DMF (Drug Master File) is a document detailing the whole manufacturing process of Germanium active pharmaceutical ingredient (API) in detail. Different forms of Germanium DMFs exist exist since differing nations have different regulations, such as Germanium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Germanium DMF submitted to regulatory agencies in the US is known as a USDMF. Germanium USDMF includes data on Germanium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Germanium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Germanium suppliers with USDMF on PharmaCompass.
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