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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35625
Submission : 2022-10-21
Status : Active
Type : II
NDC Package Code : 72775-001
Start Marketing Date : 2023-04-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
A Lutetium Lu 177 Vipivotide Tetraxetan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutetium Lu 177 Vipivotide Tetraxetan, including repackagers and relabelers. The FDA regulates Lutetium Lu 177 Vipivotide Tetraxetan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutetium Lu 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 Lu 177 Vipivotide Tetraxetan supplier is an individual or a company that provides Lutetium Lu 177 Vipivotide Tetraxetan active pharmaceutical ingredient (API) or Lutetium Lu 177 Vipivotide Tetraxetan finished formulations upon request. The Lutetium Lu 177 Vipivotide Tetraxetan suppliers may include Lutetium Lu 177 Vipivotide Tetraxetan API manufacturers, exporters, distributors and traders.
click here to find a list of Lutetium Lu 177 Vipivotide Tetraxetan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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