01 1Aurobindo Pharma Limited
02 2Esteve Quimica SA
03 1HOVIONE FARMACIENCIA S.A.
04 1Shanghai SynTheAll Pharmaceutical Co., Ltd.
01 1Tezacaftor
02 1Tezacaftor Premix
03 1Tezacaftor spray dried dispersion
04 1VX-121
05 1VX-661
01 1China
02 1India
03 1Portugal
04 2Spain
NDC Package Code : 59651-618
Start Marketing Date : 2024-01-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (40kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 57572-0724
Start Marketing Date : 2024-04-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 57572-0719
Start Marketing Date : 2021-05-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50909-1903
Start Marketing Date : 2021-02-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.8kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 24538-661
Start Marketing Date : 2018-02-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Tezacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tezacaftor, including repackagers and relabelers. The FDA regulates Tezacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Tezacaftor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tezacaftor supplier is an individual or a company that provides Tezacaftor active pharmaceutical ingredient (API) or Tezacaftor finished formulations upon request. The Tezacaftor suppliers may include Tezacaftor API manufacturers, exporters, distributors and traders.
click here to find a list of 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 Tezacaftor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 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 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 Tezacaftor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tezacaftor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tezacaftor suppliers with NDC on PharmaCompass.
We have 4 companies offering Tezacaftor
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