01 1PerkinElmer
02 3Blank
01 2CHROMIUM-51
02 1CHROMIUM-51 (DMF FORMERLY HELD BY UNION CARBIDE CORP)
03 1CHROMIUM-51 (HIGH SPECIFIC ACTIVITY ISOTOPE)
01 1U.S.A
02 3Blank
01 4Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2468
Submission : 1975-06-17
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 846
Submission : 1964-10-06
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1264
Submission : 1968-12-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1132
Submission : 1968-01-24
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Chromium-51 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chromium-51, including repackagers and relabelers. The FDA regulates Chromium-51 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chromium-51 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 Chromium-51 supplier is an individual or a company that provides Chromium-51 active pharmaceutical ingredient (API) or Chromium-51 finished formulations upon request. The Chromium-51 suppliers may include Chromium-51 API manufacturers, exporters, distributors and traders.
click here to find a list of Chromium-51 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chromium-51 DMF (Drug Master File) is a document detailing the whole manufacturing process of Chromium-51 active pharmaceutical ingredient (API) in detail. Different forms of Chromium-51 DMFs exist exist since differing nations have different regulations, such as Chromium-51 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chromium-51 DMF submitted to regulatory agencies in the US is known as a USDMF. Chromium-51 USDMF includes data on Chromium-51's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chromium-51 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chromium-51 suppliers with USDMF on PharmaCompass.
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