01 1ABX Advanced Biochemical Compounds
02 1Lantheus Medical Imaging
01 1EXAMETAZIME
02 1KIT FOR THE PREPARATION OF TC99M NM-01 FOR INJECTION
01 1Germany
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26912
Submission : 2013-09-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35175
Submission : 2020-12-09
Status : Active
Type : II
A Exametazime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exametazime, including repackagers and relabelers. The FDA regulates Exametazime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exametazime 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 Exametazime supplier is an individual or a company that provides Exametazime active pharmaceutical ingredient (API) or Exametazime finished formulations upon request. The Exametazime suppliers may include Exametazime API manufacturers, exporters, distributors and traders.
click here to find a list of Exametazime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Exametazime DMF (Drug Master File) is a document detailing the whole manufacturing process of Exametazime active pharmaceutical ingredient (API) in detail. Different forms of Exametazime DMFs exist exist since differing nations have different regulations, such as Exametazime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exametazime DMF submitted to regulatory agencies in the US is known as a USDMF. Exametazime USDMF includes data on Exametazime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exametazime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Exametazime suppliers with USDMF on PharmaCompass.
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