01 1Esteve Quimica SA
02 1Shanghai SynTheAll Pharmaceutical Co., Ltd.
01 1Elexacaftor
02 1VX-445
01 1China
02 1Spain
NDC Package Code : 57572-0717
Start Marketing Date : 2020-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 24538-445
Start Marketing Date : 2019-10-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Elexacaftor/Ivacaftor/Tezacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elexacaftor/Ivacaftor/Tezacaftor, including repackagers and relabelers. The FDA regulates Elexacaftor/Ivacaftor/Tezacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elexacaftor/Ivacaftor/Tezacaftor 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 Elexacaftor/Ivacaftor/Tezacaftor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elexacaftor/Ivacaftor/Tezacaftor supplier is an individual or a company that provides Elexacaftor/Ivacaftor/Tezacaftor active pharmaceutical ingredient (API) or Elexacaftor/Ivacaftor/Tezacaftor finished formulations upon request. The Elexacaftor/Ivacaftor/Tezacaftor suppliers may include Elexacaftor/Ivacaftor/Tezacaftor API manufacturers, exporters, distributors and traders.
click here to find a list of Elexacaftor/Ivacaftor/Tezacaftor 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 Elexacaftor/Ivacaftor/Tezacaftor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elexacaftor/Ivacaftor/Tezacaftor 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 Elexacaftor/Ivacaftor/Tezacaftor 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 Elexacaftor/Ivacaftor/Tezacaftor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elexacaftor/Ivacaftor/Tezacaftor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elexacaftor/Ivacaftor/Tezacaftor suppliers with NDC on PharmaCompass.
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