01 1Hainan Poly Pharm. Co., Ltd.
02 1Jiangsu Hengrui Pharmaceuticals Co., Ltd.
03 1MSN Life Sciences Private Limited
04 1ST Pharm Co., Ltd.
05 1Sionc Pharmaceutical Private Limited
01 2GADOBUTROL MONOHYDRATE
02 2Gadobutrol
03 1Gadobutrol Monohydrate
01 2China
02 2India
03 1South Korea
NDC Package Code : 14335-580
Start Marketing Date : 2023-11-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 57884-0035
Start Marketing Date : 2020-05-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 72640-022
Start Marketing Date : 2022-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 76055-0039
Start Marketing Date : 2019-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 73675-002
Start Marketing Date : 2023-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Gadobutrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadobutrol, including repackagers and relabelers. The FDA regulates Gadobutrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadobutrol 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 Gadobutrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadobutrol supplier is an individual or a company that provides Gadobutrol active pharmaceutical ingredient (API) or Gadobutrol finished formulations upon request. The Gadobutrol suppliers may include Gadobutrol API manufacturers, exporters, distributors and traders.
click here to find a list of Gadobutrol 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 Gadobutrol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gadobutrol 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 Gadobutrol 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 Gadobutrol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gadobutrol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gadobutrol suppliers with NDC on PharmaCompass.
We have 5 companies offering Gadobutrol
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