01 1ABX Advanced Biochemical Compounds
02 1Novartis Pharmaceuticals Corporation
03 1piCHEM Forschungs- und Entwicklungs GmbH
01 1DOTA TOC
02 1DOTA-TOC ACETATE
03 1SMT487 ACETATE (EDOTREOTIDE)
01 1Austria
02 1Germany
03 1Switzerland
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36829
Submission : 2022-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21869
Submission : 2008-08-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35060
Submission : 2022-03-16
Status : Active
Type : II
A Edotreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edotreotide, including repackagers and relabelers. The FDA regulates Edotreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edotreotide 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 Edotreotide supplier is an individual or a company that provides Edotreotide active pharmaceutical ingredient (API) or Edotreotide finished formulations upon request. The Edotreotide suppliers may include Edotreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Edotreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edotreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Edotreotide active pharmaceutical ingredient (API) in detail. Different forms of Edotreotide DMFs exist exist since differing nations have different regulations, such as Edotreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edotreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Edotreotide USDMF includes data on Edotreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edotreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edotreotide suppliers with USDMF on PharmaCompass.
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