01 1NuView Life Sciences
01 1SODIUM IODINE (I-123) DRY IODINE RADIOCHEMICAL
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23879
Submission : 2010-06-05
Status : Active
Type : II
A Iodide-123 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iodide-123, including repackagers and relabelers. The FDA regulates Iodide-123 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iodide-123 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 Iodide-123 supplier is an individual or a company that provides Iodide-123 active pharmaceutical ingredient (API) or Iodide-123 finished formulations upon request. The Iodide-123 suppliers may include Iodide-123 API manufacturers, exporters, distributors and traders.
click here to find a list of Iodide-123 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iodide-123 DMF (Drug Master File) is a document detailing the whole manufacturing process of Iodide-123 active pharmaceutical ingredient (API) in detail. Different forms of Iodide-123 DMFs exist exist since differing nations have different regulations, such as Iodide-123 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iodide-123 DMF submitted to regulatory agencies in the US is known as a USDMF. Iodide-123 USDMF includes data on Iodide-123's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iodide-123 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iodide-123 suppliers with USDMF on PharmaCompass.
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