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Looking for 1195768-06-9 / Dabrafenib Mesylate API manufacturers, exporters & distributors?

Dabrafenib Mesylate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dabrafenib Mesylate

Synonyms

1195768-06-9, Dabrafenib (mesylate), Gsk 2118436b, Dabrafenib mesilate, Dabrafenib mesylate [usan], Unii-b6dc89i63e

Cas Number

1195768-06-9

Unique Ingredient Identifier (UNII)

B6DC89I63E

About Dabrafenib Mesylate

Dabrafenib Mesylate is the mesylate salt form of dabrafenib, an orally bioavailable inhibitor of B-raf (BRAF) protein with potential antineoplastic activity. Dabrafenib selectively binds to and inhibits the activity of B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. B-raf belongs to the raf/mil family of serine/threonine protein kinases and plays a role in regulating the MAP kinase/ERKs signaling pathway, which may be constitutively activated due to BRAF gene mutations.

Dabrafenib Manufacturers

A Dabrafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabrafenib, including repackagers and relabelers. The FDA regulates Dabrafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabrafenib 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 Dabrafenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dabrafenib Suppliers

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

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

Dabrafenib USDMF

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

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

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

Dabrafenib WC

A Dabrafenib written confirmation (Dabrafenib WC) is an official document issued by a regulatory agency to a Dabrafenib manufacturer, verifying that the manufacturing facility of a Dabrafenib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dabrafenib APIs or Dabrafenib finished pharmaceutical products to another nation, regulatory agencies frequently require a Dabrafenib WC (written confirmation) as part of the regulatory process.

click here to find a list of Dabrafenib suppliers with Written Confirmation (WC) on PharmaCompass.

Dabrafenib NDC

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 Dabrafenib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dabrafenib API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Dabrafenib 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Dabrafenib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dabrafenib NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Dabrafenib suppliers with NDC on PharmaCompass.

Dabrafenib GMP

Dabrafenib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Dabrafenib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dabrafenib GMP manufacturer or Dabrafenib GMP API supplier for your needs.

Dabrafenib CoA

A Dabrafenib CoA (Certificate of Analysis) is a formal document that attests to Dabrafenib's compliance with Dabrafenib specifications and serves as a tool for batch-level quality control.

Dabrafenib CoA mostly includes findings from lab analyses of a specific batch. For each Dabrafenib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Dabrafenib may be tested according to a variety of international standards, such as European Pharmacopoeia (Dabrafenib EP), Dabrafenib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dabrafenib USP).

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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