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List of Drug Master Files (DMF) of Brexanolone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 BREXANOLONE (1)

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34802
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2020-04-24
Complete
2020-06-03
2020-05-15
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Looking for 516-54-1 / Brexanolone API manufacturers, exporters & distributors?

Brexanolone manufacturers, exporters & distributors 1

63

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.

API | Excipient name

Brexanolone

Synonyms

516-54-1, Allopregnan-3alpha-ol-20-one, Allotetrahydroprogesterone, Sage-547, Zulresso, 3alpha-hydroxy-5alpha-pregnan-20-one

Cas Number

516-54-1

Unique Ingredient Identifier (UNII)

S39XZ5QV8Y

About Brexanolone

A pregnane found in the urine of pregnant women and sows. It has anesthetic, hypnotic, and sedative properties.

Brexanolone Manufacturers

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.

Brexanolone Suppliers

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.

Brexanolone USDMF

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.

Brexanolone Manufacturers | Traders | Suppliers

Brexanolone Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Brexanolone

Get in contact with the supplier of your choice:

  1. Curia
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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