US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Apalutamide 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 Apalutamide manufacturer or Apalutamide supplier for your needs.
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PharmaCompass also assists you with knowing the Apalutamide API Price utilized in the formulation of products. Apalutamide API Price is not always fixed or binding as the Apalutamide Price is obtained through a variety of data sources. The Apalutamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Apalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apalutamide, including repackagers and relabelers. The FDA regulates Apalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apalutamide 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 Apalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apalutamide supplier is an individual or a company that provides Apalutamide active pharmaceutical ingredient (API) or Apalutamide finished formulations upon request. The Apalutamide suppliers may include Apalutamide API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Apalutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apalutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Apalutamide active pharmaceutical ingredient (API) in detail. Different forms of Apalutamide DMFs exist exist since differing nations have different regulations, such as Apalutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apalutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Apalutamide USDMF includes data on Apalutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apalutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Apalutamide written confirmation (Apalutamide WC) is an official document issued by a regulatory agency to a Apalutamide manufacturer, verifying that the manufacturing facility of a Apalutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Apalutamide APIs or Apalutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Apalutamide WC (written confirmation) as part of the regulatory process.
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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 Apalutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Apalutamide API and other APIs are published in this directory by the FDA.
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 Apalutamide 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.
The NDC directory also contains data on finished compounded human drug products that contain Apalutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Apalutamide NDC to their finished compounded human drug products, they may choose to do so.
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Apalutamide 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 Apalutamide 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 Apalutamide GMP manufacturer or Apalutamide GMP API supplier for your needs.
A Apalutamide CoA (Certificate of Analysis) is a formal document that attests to Apalutamide's compliance with Apalutamide specifications and serves as a tool for batch-level quality control.
Apalutamide CoA mostly includes findings from lab analyses of a specific batch. For each Apalutamide 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.
Apalutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Apalutamide EP), Apalutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Apalutamide USP).