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API SUPPLIERS
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USDMF
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API Imports and Exports
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INTERMEDIATES SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Nilandron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilandron, including repackagers and relabelers. The FDA regulates Nilandron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilandron 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 Nilandron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilandron supplier is an individual or a company that provides Nilandron active pharmaceutical ingredient (API) or Nilandron finished formulations upon request. The Nilandron suppliers may include Nilandron API manufacturers, exporters, distributors and traders.
click here to find a list of Nilandron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilandron DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilandron active pharmaceutical ingredient (API) in detail. Different forms of Nilandron DMFs exist exist since differing nations have different regulations, such as Nilandron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilandron DMF submitted to regulatory agencies in the US is known as a USDMF. Nilandron USDMF includes data on Nilandron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilandron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilandron suppliers with USDMF on PharmaCompass.
A Nilandron CEP of the European Pharmacopoeia monograph is often referred to as a Nilandron Certificate of Suitability (COS). The purpose of a Nilandron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nilandron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nilandron to their clients by showing that a Nilandron CEP has been issued for it. The manufacturer submits a Nilandron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nilandron CEP holder for the record. Additionally, the data presented in the Nilandron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nilandron DMF.
A Nilandron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nilandron 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 Nilandron suppliers with CEP (COS) on PharmaCompass.
A Nilandron written confirmation (Nilandron WC) is an official document issued by a regulatory agency to a Nilandron manufacturer, verifying that the manufacturing facility of a Nilandron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nilandron APIs or Nilandron finished pharmaceutical products to another nation, regulatory agencies frequently require a Nilandron WC (written confirmation) as part of the regulatory process.
click here to find a list of Nilandron 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 Nilandron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nilandron 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 Nilandron 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 Nilandron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nilandron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nilandron suppliers with NDC on PharmaCompass.
Nilandron 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 Nilandron 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 Nilandron GMP manufacturer or Nilandron GMP API supplier for your needs.
A Nilandron CoA (Certificate of Analysis) is a formal document that attests to Nilandron's compliance with Nilandron specifications and serves as a tool for batch-level quality control.
Nilandron CoA mostly includes findings from lab analyses of a specific batch. For each Nilandron 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.
Nilandron may be tested according to a variety of international standards, such as European Pharmacopoeia (Nilandron EP), Nilandron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nilandron USP).
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