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Looking for 943319-70-8 / Ponatinib API manufacturers, exporters & distributors?

Ponatinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ponatinib

Synonyms

943319-70-8, Ap24534, Ponatinib (ap24534), Ap 24534, Ap-24534, 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide

Cas Number

943319-70-8

Unique Ingredient Identifier (UNII)

4340891KFS

About Ponatinib

Ponatinib is an orally bioavailable multitargeted receptor tyrosine kinase (RTK) inhibitor with potential antiangiogenic and antineoplastic activities. Ponatinib inhibits unmutated and all mutated forms of Bcr-Abl, including T315I, the highly drug therapy-resistant missense mutation of Bcr-Abl. This agent also inhibits other tyrosine kinases including those associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptors (FGFRs); in addition, it inhibits the tyrosine kinase receptor TIE2 and FMS-related tyrosine kinase receptor-3 (Flt3). RTK inhibition by ponatinib may result in the inhibition of cellular proliferation and angiogenesis and may induce cell death. Bcr-Abl is a fusion tyrosine kinase encoded by the Philadelphia chromosome.

Ponatinib Manufacturers

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

Ponatinib Suppliers

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

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

Ponatinib USDMF

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

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

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

Ponatinib WC

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

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

Ponatinib 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 Ponatinib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ponatinib 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 Ponatinib 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 Ponatinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ponatinib NDC to their finished compounded human drug products, they may choose to do so.

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

Ponatinib GMP

Ponatinib 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 Ponatinib 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 Ponatinib GMP manufacturer or Ponatinib GMP API supplier for your needs.

Ponatinib CoA

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

Ponatinib CoA mostly includes findings from lab analyses of a specific batch. For each Ponatinib 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.

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