01 1piCHEM Forschungs- und Entwicklungs GmbH
01 1VIPIVOTIDE TETRAXETAN
01 1Austria
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35625
Submission : 2022-10-21
Status : Active
Type : II
A Lutetium-177 Vipivotide Tetraxetan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutetium-177 Vipivotide Tetraxetan, including repackagers and relabelers. The FDA regulates Lutetium-177 Vipivotide Tetraxetan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutetium-177 Vipivotide Tetraxetan 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 Lutetium-177 Vipivotide Tetraxetan supplier is an individual or a company that provides Lutetium-177 Vipivotide Tetraxetan active pharmaceutical ingredient (API) or Lutetium-177 Vipivotide Tetraxetan finished formulations upon request. The Lutetium-177 Vipivotide Tetraxetan suppliers may include Lutetium-177 Vipivotide Tetraxetan API manufacturers, exporters, distributors and traders.
click here to find a list of Lutetium-177 Vipivotide Tetraxetan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lutetium-177 Vipivotide Tetraxetan DMF (Drug Master File) is a document detailing the whole manufacturing process of Lutetium-177 Vipivotide Tetraxetan active pharmaceutical ingredient (API) in detail. Different forms of Lutetium-177 Vipivotide Tetraxetan DMFs exist exist since differing nations have different regulations, such as Lutetium-177 Vipivotide Tetraxetan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lutetium-177 Vipivotide Tetraxetan DMF submitted to regulatory agencies in the US is known as a USDMF. Lutetium-177 Vipivotide Tetraxetan USDMF includes data on Lutetium-177 Vipivotide Tetraxetan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lutetium-177 Vipivotide Tetraxetan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lutetium-177 Vipivotide Tetraxetan suppliers with USDMF on PharmaCompass.
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