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Looking for 571190-30-2 / Palbociclib API manufacturers, exporters & distributors?

Palbociclib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Palbociclib

Synonyms

571190-30-2, Pd-0332991, Ibrance, Pd0332991, Pd 0332991, Palbociclib free base

Cas Number

571190-30-2

Unique Ingredient Identifier (UNII)

G9ZF61LE7G

About Palbociclib

Palbociclib is an orally available cyclin-dependent kinase (CDK) inhibitor with potential antineoplastic activity. Palbociclib selectively inhibits cyclin-dependent kinase 4 (CDK4) and 6 (CDK6), thereby inhibiting retinoblastoma (Rb) protein phosphorylation early in the G1 phase leading to cell cycle arrest. This suppresses DNA replication and decreases tumor cell proliferation. CDK4 and 6 are serine/threonine kinases that are upregulated in many tumor cell types and play a key role in the regulation of cell cycle progression.

Palbociclib Manufacturers

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

Palbociclib Suppliers

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

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

Palbociclib USDMF

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

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

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

Palbociclib WC

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

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

Palbociclib 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 Palbociclib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Palbociclib GMP

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

Palbociclib CoA

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

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

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