Vernakalant

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

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CARDIOME DEVELOPMENT AG

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RSD1235 DRUG SUBSTANCE

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DMF Number

19171

Status

Inactive

Submission Date

2006-03-14

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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Looking for 794466-70-9 / Vernakalant API manufacturers, exporters & distributors?

PharmaCompass offers a list of Vernakalant 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 Vernakalant manufacturer or Vernakalant supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vernakalant manufacturer or Vernakalant supplier.

PharmaCompass also assists you with knowing the Vernakalant API Price utilized in the formulation of products. Vernakalant API Price is not always fixed or binding as the Vernakalant Price is obtained through a variety of data sources. The Vernakalant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vernakalant

Synonyms

794466-70-9, Vemakalant, Rsd1235, Rsd-1235, (3r)-1-((1r,2r)-2-(2-(3,4-dimethoxyphenyl)ethoxy)cyclohexyl)pyrrolidin-3-ol, 9g468c8b13

Cas Number

794466-70-9

Unique Ingredient Identifier (UNII)

9G468C8B13

About Vernakalant

Vernakalant was developed by Cardiome Pharma as as an antiarrhythmic drug intended for rapid conversion of atrial fibrillation to sinus rhythm. It acts as an atypical class III antiarrhythmic drug that potentiates its effect in higher heart rates. Intravenous formulation was approved in Europe in September 2010 as Brinavess and in Canada in April 2017. It is an investigational drug under regulatory review by FDA.

Vernakalant Manufacturers

A Vernakalant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vernakalant, including repackagers and relabelers. The FDA regulates Vernakalant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vernakalant API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Vernakalant Suppliers

A Vernakalant supplier is an individual or a company that provides Vernakalant active pharmaceutical ingredient (API) or Vernakalant finished formulations upon request. The Vernakalant suppliers may include Vernakalant API manufacturers, exporters, distributors and traders.

click here to find a list of Vernakalant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vernakalant USDMF

A Vernakalant DMF (Drug Master File) is a document detailing the whole manufacturing process of Vernakalant active pharmaceutical ingredient (API) in detail. Different forms of Vernakalant DMFs exist exist since differing nations have different regulations, such as Vernakalant USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Vernakalant DMF submitted to regulatory agencies in the US is known as a USDMF. Vernakalant USDMF includes data on Vernakalant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vernakalant USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Vernakalant suppliers with USDMF on PharmaCompass.

Vernakalant Manufacturers | Traders | Suppliers

We have 1 companies offering Vernakalant

Get in contact with the supplier of your choice:

CARDIOME DEVELOPMENT AG

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.