01 1Formosa Laboratories, Inc.
02 1Hainan Poly Pharm. Co., Ltd.
03 1Jiangsu Hengrui Pharmaceuticals Co., Ltd.
04 1SIONC PHARMACEUTICALS PVT LTD
01 3Gadoterate Meglumine
02 1Gadoterate meglumine
01 2China
02 1India
03 1Taiwan
NDC Package Code : 66499-0066
Start Marketing Date : 2019-09-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14335-310
Start Marketing Date : 2022-05-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 57884-0037
Start Marketing Date : 2020-03-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 76055-1003
Start Marketing Date : 2022-12-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
A Dotarem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dotarem, including repackagers and relabelers. The FDA regulates Dotarem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dotarem 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 Dotarem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dotarem supplier is an individual or a company that provides Dotarem active pharmaceutical ingredient (API) or Dotarem finished formulations upon request. The Dotarem suppliers may include Dotarem API manufacturers, exporters, distributors and traders.
click here to find a list of Dotarem 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 Dotarem as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dotarem 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 Dotarem 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 Dotarem and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dotarem NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dotarem suppliers with NDC on PharmaCompass.
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