01 1NuView Life Sciences
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01 1BULK RADIOCHEMICAL THALLIUM-201 CHLORIDE AND THALLIUM-201 STERILE SOLUTION
02 1THALLIUM TL-201 RADIOCHEMICAL
01 1U.S.A
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01 1Active
02 1Inactive
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14398
Submission : 1999-09-10
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11950
Submission : 1996-05-01
Status : Inactive
Type : II
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A Thallium-201 Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thallium-201 Chloride, including repackagers and relabelers. The FDA regulates Thallium-201 Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thallium-201 Chloride 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 Thallium-201 Chloride supplier is an individual or a company that provides Thallium-201 Chloride active pharmaceutical ingredient (API) or Thallium-201 Chloride finished formulations upon request. The Thallium-201 Chloride suppliers may include Thallium-201 Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Thallium-201 Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thallium-201 Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Thallium-201 Chloride active pharmaceutical ingredient (API) in detail. Different forms of Thallium-201 Chloride DMFs exist exist since differing nations have different regulations, such as Thallium-201 Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thallium-201 Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Thallium-201 Chloride USDMF includes data on Thallium-201 Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thallium-201 Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thallium-201 Chloride suppliers with USDMF on PharmaCompass.
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