01 2IRE Elit
02 1MDS NORDION
03 1Nordion Canada
04 1UNIV MISSOURI RESEARCH REACTOR CENTER
01 2SODIUM IODIDE I-131
02 1SODIUM IODIDE I-131 SOLUTION
03 1SODIUM IODIDE I131 (FISSION)
04 1SODIUM [1311] IODIDE (LEU FISSION)
01 2Belgium
02 2Canada
03 1U.S.A
01 3Active
02 2Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15505
Submission : 2001-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36442
Submission : 2022-01-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9229
Submission : 1991-07-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6372
Submission : 1986-05-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-08-29
DMF Number : 32854
Submission : 2018-08-10
Status : Active
Type : II
A Sodium Iodide-131 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Iodide-131, including repackagers and relabelers. The FDA regulates Sodium Iodide-131 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Iodide-131 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 Sodium Iodide-131 supplier is an individual or a company that provides Sodium Iodide-131 active pharmaceutical ingredient (API) or Sodium Iodide-131 finished formulations upon request. The Sodium Iodide-131 suppliers may include Sodium Iodide-131 API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Iodide-131 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Iodide-131 DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Iodide-131 active pharmaceutical ingredient (API) in detail. Different forms of Sodium Iodide-131 DMFs exist exist since differing nations have different regulations, such as Sodium Iodide-131 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Iodide-131 DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Iodide-131 USDMF includes data on Sodium Iodide-131's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Iodide-131 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Iodide-131 suppliers with USDMF on PharmaCompass.
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