01 1HOVIONE FARMACIENCIA S.A.
02 1OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED
03 1VALARY LAB PRIVATE LIMITED
01 2Pralsetinib
02 1Pralsetinib SDD intermediate
01 1Italy
02 1Portugal
03 1Blank
NDC Package Code : 50909-1905
Start Marketing Date : 2022-12-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 73005-0010
Start Marketing Date : 2024-02-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 81955-0018
Start Marketing Date : 2020-09-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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A Pralsetinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pralsetinib, including repackagers and relabelers. The FDA regulates Pralsetinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pralsetinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Pralsetinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pralsetinib supplier is an individual or a company that provides Pralsetinib active pharmaceutical ingredient (API) or Pralsetinib finished formulations upon request. The Pralsetinib suppliers may include Pralsetinib API manufacturers, exporters, distributors and traders.
click here to find a list of Pralsetinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Pralsetinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pralsetinib 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 Pralsetinib 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 Pralsetinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pralsetinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pralsetinib suppliers with NDC on PharmaCompass.
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