01 1Brookhaven national laboratory
02 2Oak Ridge National Laboratory
01 1ACTINIUM-225 NITRATE
02 1ACTINIUM-225 NITRATE (THORIUM-229 DECAY PRODUCT)
03 1ACTINIUM-225 NITRATE (ACCELERATOR-PRODUCED)
01 3U.S.A
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38736
Submission : 2023-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35378
Submission : 2020-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34308
Submission : 2019-12-20
Status : Active
Type : II
A Actinium-225 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Actinium-225, including repackagers and relabelers. The FDA regulates Actinium-225 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Actinium-225 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 Actinium-225 supplier is an individual or a company that provides Actinium-225 active pharmaceutical ingredient (API) or Actinium-225 finished formulations upon request. The Actinium-225 suppliers may include Actinium-225 API manufacturers, exporters, distributors and traders.
click here to find a list of Actinium-225 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Actinium-225 DMF (Drug Master File) is a document detailing the whole manufacturing process of Actinium-225 active pharmaceutical ingredient (API) in detail. Different forms of Actinium-225 DMFs exist exist since differing nations have different regulations, such as Actinium-225 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Actinium-225 DMF submitted to regulatory agencies in the US is known as a USDMF. Actinium-225 USDMF includes data on Actinium-225's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Actinium-225 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Actinium-225 suppliers with USDMF on PharmaCompass.
We have 2 companies offering Actinium-225
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
