US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Enzalutamide 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 Enzalutamide manufacturer or Enzalutamide supplier for your needs.
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PharmaCompass also assists you with knowing the Enzalutamide API Price utilized in the formulation of products. Enzalutamide API Price is not always fixed or binding as the Enzalutamide Price is obtained through a variety of data sources. The Enzalutamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Enzalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enzalutamide, including repackagers and relabelers. The FDA regulates Enzalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enzalutamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Enzalutamide supplier is an individual or a company that provides Enzalutamide active pharmaceutical ingredient (API) or Enzalutamide finished formulations upon request. The Enzalutamide suppliers may include Enzalutamide API manufacturers, exporters, distributors and traders.
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A Enzalutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Enzalutamide active pharmaceutical ingredient (API) in detail. Different forms of Enzalutamide DMFs exist exist since differing nations have different regulations, such as Enzalutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enzalutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Enzalutamide USDMF includes data on Enzalutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enzalutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Enzalutamide Drug Master File in Korea (Enzalutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Enzalutamide. The MFDS reviews the Enzalutamide KDMF as part of the drug registration process and uses the information provided in the Enzalutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Enzalutamide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Enzalutamide API can apply through the Korea Drug Master File (KDMF).
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A Enzalutamide written confirmation (Enzalutamide WC) is an official document issued by a regulatory agency to a Enzalutamide manufacturer, verifying that the manufacturing facility of a Enzalutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Enzalutamide APIs or Enzalutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Enzalutamide 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 Enzalutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Enzalutamide 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 Enzalutamide 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 Enzalutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Enzalutamide NDC to their finished compounded human drug products, they may choose to do so.
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Enzalutamide 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 Enzalutamide 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 Enzalutamide GMP manufacturer or Enzalutamide GMP API supplier for your needs.
A Enzalutamide CoA (Certificate of Analysis) is a formal document that attests to Enzalutamide's compliance with Enzalutamide specifications and serves as a tool for batch-level quality control.
Enzalutamide CoA mostly includes findings from lab analyses of a specific batch. For each Enzalutamide 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.
Enzalutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Enzalutamide EP), Enzalutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enzalutamide USP).