01 2Isotope Technologies Munich
02 1Blank
01 1LU-177 N.C.A. PRECURSOR RADIOPHARMACEUTICAL PRECURSOR SOLUTION
02 1LUTETIUM (177LU) SOLUTION FOR RADIOLABELING
03 1LUTETIUM-177 RADIOCHEMICAL SOLUTION [LU-177]
01 2Germany
02 1Blank
01 3Active
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31540
Submission : 2017-11-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-23
Pay. Date : 2023-06-20
DMF Number : 35008
Submission : 2020-09-21
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32943
Submission : 2018-07-11
Status : Active
Type : II
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A Lutetium-177 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutetium-177, including repackagers and relabelers. The FDA regulates Lutetium-177 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutetium-177 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 Lutetium-177 supplier is an individual or a company that provides Lutetium-177 active pharmaceutical ingredient (API) or Lutetium-177 finished formulations upon request. The Lutetium-177 suppliers may include Lutetium-177 API manufacturers, exporters, distributors and traders.
click here to find a list of Lutetium-177 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lutetium-177 DMF (Drug Master File) is a document detailing the whole manufacturing process of Lutetium-177 active pharmaceutical ingredient (API) in detail. Different forms of Lutetium-177 DMFs exist exist since differing nations have different regulations, such as Lutetium-177 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lutetium-177 DMF submitted to regulatory agencies in the US is known as a USDMF. Lutetium-177 USDMF includes data on Lutetium-177's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lutetium-177 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lutetium-177 suppliers with USDMF on PharmaCompass.
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