01 1Ash Stevens LLC
02 1Curia Spain S.A.U.
03 1zhejiang xianju pharmaceutical co., Ltd.
01 2Brexanolone
02 1brexanolone
01 1China
02 2U.S.A
NDC Package Code : 48957-0097
Start Marketing Date : 2019-06-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65089-0060
Start Marketing Date : 2021-02-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 60722-3015
Start Marketing Date : 2022-07-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Brexanolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brexanolone, including repackagers and relabelers. The FDA regulates Brexanolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brexanolone 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 Brexanolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brexanolone supplier is an individual or a company that provides Brexanolone active pharmaceutical ingredient (API) or Brexanolone finished formulations upon request. The Brexanolone suppliers may include Brexanolone API manufacturers, exporters, distributors and traders.
click here to find a list of Brexanolone 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 Brexanolone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brexanolone 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 Brexanolone 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 Brexanolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brexanolone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brexanolone suppliers with NDC on PharmaCompass.
We have 3 companies offering Brexanolone
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