01 1Curia
02 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 2BREXANOLONE
01 1China
02 1U.S.A
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-03
Pay. Date : 2020-05-15
DMF Number : 34802
Submission : 2020-04-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39854
Submission : 2024-04-16
Status : Active
Type : II
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PharmaCompass offers a list of Brexanolone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Brexanolone manufacturer or Brexanolone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brexanolone manufacturer or Brexanolone supplier.
PharmaCompass also assists you with knowing the Brexanolone API Price utilized in the formulation of products. Brexanolone API Price is not always fixed or binding as the Brexanolone Price is obtained through a variety of data sources. The Brexanolone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
A Brexanolone DMF (Drug Master File) is a document detailing the whole manufacturing process of Brexanolone active pharmaceutical ingredient (API) in detail. Different forms of Brexanolone DMFs exist exist since differing nations have different regulations, such as Brexanolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brexanolone DMF submitted to regulatory agencies in the US is known as a USDMF. Brexanolone USDMF includes data on Brexanolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brexanolone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brexanolone suppliers with USDMF on PharmaCompass.
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