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Looking for 1032900-25-6 / Ceritinib API manufacturers, exporters & distributors?

Ceritinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ceritinib

Synonyms

Ldk378, 1032900-25-6, Zykadia, Ldk-378, Nvp-ldk378-nx, Ldk 378

Cas Number

1032900-25-6

Unique Ingredient Identifier (UNII)

K418KG2GET

About Ceritinib

Ceritinib is an orally available inhibitor of the receptor tyrosine kinase activity of anaplastic lymphoma kinase (ALK) with antineoplastic activity. Upon administration, ceritinib binds to and inhibits wild-type ALK kinase, ALK fusion proteins and ALK point mutation variants. Inhibition of ALK leads to both the disruption of ALK-mediated signaling and the inhibition of cell growth in ALK-overexpressing tumor cells. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development. ALK dysregulation and gene rearrangements are associated with a variety of tumor cell types.

Ceritinib Manufacturers

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

Ceritinib Suppliers

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

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

Ceritinib USDMF

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

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

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

Ceritinib WC

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

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

Ceritinib 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 Ceritinib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ceritinib GMP

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

Ceritinib CoA

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

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

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