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ABOUT THIS PAGE
A Darolutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darolutamide, including repackagers and relabelers. The FDA regulates Darolutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darolutamide 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 Darolutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Darolutamide supplier is an individual or a company that provides Darolutamide active pharmaceutical ingredient (API) or Darolutamide finished formulations upon request. The Darolutamide suppliers may include Darolutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Darolutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Darolutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Darolutamide active pharmaceutical ingredient (API) in detail. Different forms of Darolutamide DMFs exist exist since differing nations have different regulations, such as Darolutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Darolutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Darolutamide USDMF includes data on Darolutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darolutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Darolutamide suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Darolutamide Drug Master File in Korea (Darolutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Darolutamide. The MFDS reviews the Darolutamide KDMF as part of the drug registration process and uses the information provided in the Darolutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Darolutamide 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 Darolutamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Darolutamide suppliers with KDMF on PharmaCompass.
A Darolutamide written confirmation (Darolutamide WC) is an official document issued by a regulatory agency to a Darolutamide manufacturer, verifying that the manufacturing facility of a Darolutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Darolutamide APIs or Darolutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Darolutamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Darolutamide suppliers with Written Confirmation (WC) on PharmaCompass.
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 Darolutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Darolutamide 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 Darolutamide 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 Darolutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Darolutamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Darolutamide suppliers with NDC on PharmaCompass.
Darolutamide 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 Darolutamide 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 Darolutamide GMP manufacturer or Darolutamide GMP API supplier for your needs.
A Darolutamide CoA (Certificate of Analysis) is a formal document that attests to Darolutamide's compliance with Darolutamide specifications and serves as a tool for batch-level quality control.
Darolutamide CoA mostly includes findings from lab analyses of a specific batch. For each Darolutamide 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.
Darolutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Darolutamide EP), Darolutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Darolutamide USP).
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