01 1Apicore Pharmaceuticals Private Limited
02 1Bamboo US Bidco LCC
03 1GP PHARM SA
04 1MSN Laboratories Private Limited
01 1LURBINECTEDIN
02 2Lurbinectedin
03 1lurbinectedin
01 2India
02 1Spain
03 1Blank
NDC Package Code : 42973-353
Start Marketing Date : 2023-05-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 69112-102
Start Marketing Date : 2020-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (4mg/8mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 54893-0508
Start Marketing Date : 2024-03-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 83703-583
Start Marketing Date : 2020-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (0.5mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
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A Lurbinectedin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurbinectedin, including repackagers and relabelers. The FDA regulates Lurbinectedin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurbinectedin 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 Lurbinectedin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurbinectedin supplier is an individual or a company that provides Lurbinectedin active pharmaceutical ingredient (API) or Lurbinectedin finished formulations upon request. The Lurbinectedin suppliers may include Lurbinectedin API manufacturers, exporters, distributors and traders.
click here to find a list of Lurbinectedin 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 Lurbinectedin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lurbinectedin 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 Lurbinectedin 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 Lurbinectedin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lurbinectedin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lurbinectedin suppliers with NDC on PharmaCompass.
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