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 : Complete
Rev. Date : 2023-06-23
Pay. Date : 2023-06-20
DMF Number : 35008
Submission : 2020-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31540
Submission : 2017-11-01
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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PharmaCompass offers a list of Lutetium-177 API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lutetium-177 manufacturer or Lutetium-177 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lutetium-177 manufacturer or Lutetium-177 supplier.
PharmaCompass also assists you with knowing the Lutetium-177 API Price utilized in the formulation of products. Lutetium-177 API Price is not always fixed or binding as the Lutetium-177 Price is obtained through a variety of data sources. The Lutetium-177 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 177Lu manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 177Lu, including repackagers and relabelers. The FDA regulates 177Lu manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 177Lu 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 177Lu supplier is an individual or a company that provides 177Lu active pharmaceutical ingredient (API) or 177Lu finished formulations upon request. The 177Lu suppliers may include 177Lu API manufacturers, exporters, distributors and traders.
click here to find a list of 177Lu suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 177Lu DMF (Drug Master File) is a document detailing the whole manufacturing process of 177Lu active pharmaceutical ingredient (API) in detail. Different forms of 177Lu DMFs exist exist since differing nations have different regulations, such as 177Lu USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 177Lu DMF submitted to regulatory agencies in the US is known as a USDMF. 177Lu USDMF includes data on 177Lu's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 177Lu USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 177Lu suppliers with USDMF on PharmaCompass.
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