01 1Brookhaven national laboratory
02 1GIP Arronax
03 1LOS ALAMOS NATIONAL LABORATORY DEPT ENERGY
04 1MANHATTAN ISOTOPE TECHNOLOGY LLC
05 2Nordion Canada
06 1Blank
01 3STRONTIUM-82
02 1STRONTIUM-82 (P:4N, 6N)
03 1STRONTIUM-82 CHLORIDE (SPALLATION)
04 1STRONTIUM-82 CHLORIDE SOLUTION
05 1STRONTIUM-82 DRUG SUBSTANCE
01 2Canada
02 1France
03 3U.S.A
04 1Blank
01 4Active
02 3Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5531
Submission : 1984-07-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31615
Submission : 2017-06-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5515
Submission : 1984-07-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26411
Submission : 2012-08-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9095
Submission : 1991-04-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5551
Submission : 1984-06-27
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11709
Submission : 1995-10-02
Status : Inactive
Type : II
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A Strontium-82 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Strontium-82, including repackagers and relabelers. The FDA regulates Strontium-82 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Strontium-82 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 Strontium-82 supplier is an individual or a company that provides Strontium-82 active pharmaceutical ingredient (API) or Strontium-82 finished formulations upon request. The Strontium-82 suppliers may include Strontium-82 API manufacturers, exporters, distributors and traders.
click here to find a list of Strontium-82 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Strontium-82 DMF (Drug Master File) is a document detailing the whole manufacturing process of Strontium-82 active pharmaceutical ingredient (API) in detail. Different forms of Strontium-82 DMFs exist exist since differing nations have different regulations, such as Strontium-82 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Strontium-82 DMF submitted to regulatory agencies in the US is known as a USDMF. Strontium-82 USDMF includes data on Strontium-82's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Strontium-82 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Strontium-82 suppliers with USDMF on PharmaCompass.
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