01 1ABX advanced biochemical compounds Biochemische Forschungsreagenzien GmbH
02 1piCHEM Forschungs-und Entwicklungs GmbH
01 1PSMA-617
02 1VIPIVOTIDE TETRAXETAN
01 1Austria
02 1U.S.A
NDC Package Code : 71934-0024
Start Marketing Date : 2022-03-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
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.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Lutetium Lu 177 Vipivotide Tetraxetan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lutetium Lu 177 Vipivotide Tetraxetan API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Lutetium Lu 177 Vipivotide Tetraxetan as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Lutetium Lu 177 Vipivotide Tetraxetan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lutetium Lu 177 Vipivotide Tetraxetan NDC to their finished compounded human drug products, they may choose to do so.
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