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API SUPPLIERS
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USDMF
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INTERMEDIATES SUPPLIERS
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ABOUT THIS PAGE
A Nilutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilutamide, including repackagers and relabelers. The FDA regulates Nilutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilutamide 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 Nilutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilutamide supplier is an individual or a company that provides Nilutamide active pharmaceutical ingredient (API) or Nilutamide finished formulations upon request. The Nilutamide suppliers may include Nilutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Nilutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilutamide active pharmaceutical ingredient (API) in detail. Different forms of Nilutamide DMFs exist exist since differing nations have different regulations, such as Nilutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Nilutamide USDMF includes data on Nilutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilutamide suppliers with USDMF on PharmaCompass.
A Nilutamide CEP of the European Pharmacopoeia monograph is often referred to as a Nilutamide Certificate of Suitability (COS). The purpose of a Nilutamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nilutamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nilutamide to their clients by showing that a Nilutamide CEP has been issued for it. The manufacturer submits a Nilutamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nilutamide CEP holder for the record. Additionally, the data presented in the Nilutamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nilutamide DMF.
A Nilutamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nilutamide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Nilutamide suppliers with CEP (COS) on PharmaCompass.
A Nilutamide written confirmation (Nilutamide WC) is an official document issued by a regulatory agency to a Nilutamide manufacturer, verifying that the manufacturing facility of a Nilutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nilutamide APIs or Nilutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Nilutamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Nilutamide 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 Nilutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nilutamide 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 Nilutamide 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 Nilutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nilutamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nilutamide suppliers with NDC on PharmaCompass.
Nilutamide 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 Nilutamide 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 Nilutamide GMP manufacturer or Nilutamide GMP API supplier for your needs.
A Nilutamide CoA (Certificate of Analysis) is a formal document that attests to Nilutamide's compliance with Nilutamide specifications and serves as a tool for batch-level quality control.
Nilutamide CoA mostly includes findings from lab analyses of a specific batch. For each Nilutamide 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.
Nilutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Nilutamide EP), Nilutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nilutamide USP).
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