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PharmaCompass offers a list of Niacin 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 Niacin manufacturer or Niacin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Niacin manufacturer or Niacin supplier.
PharmaCompass also assists you with knowing the Niacin API Price utilized in the formulation of products. Niacin API Price is not always fixed or binding as the Niacin Price is obtained through a variety of data sources. The Niacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Niacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niacin, including repackagers and relabelers. The FDA regulates Niacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niacin 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 Niacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niacin supplier is an individual or a company that provides Niacin active pharmaceutical ingredient (API) or Niacin finished formulations upon request. The Niacin suppliers may include Niacin API manufacturers, exporters, distributors and traders.
click here to find a list of Niacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Niacin active pharmaceutical ingredient (API) in detail. Different forms of Niacin DMFs exist exist since differing nations have different regulations, such as Niacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niacin DMF submitted to regulatory agencies in the US is known as a USDMF. Niacin USDMF includes data on Niacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niacin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Niacin Drug Master File in Japan (Niacin JDMF) empowers Niacin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Niacin JDMF during the approval evaluation for pharmaceutical products. At the time of Niacin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Niacin suppliers with JDMF on PharmaCompass.
A Niacin CEP of the European Pharmacopoeia monograph is often referred to as a Niacin Certificate of Suitability (COS). The purpose of a Niacin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Niacin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Niacin to their clients by showing that a Niacin CEP has been issued for it. The manufacturer submits a Niacin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Niacin CEP holder for the record. Additionally, the data presented in the Niacin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Niacin DMF.
A Niacin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Niacin 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 Niacin suppliers with CEP (COS) on PharmaCompass.
A Niacin written confirmation (Niacin WC) is an official document issued by a regulatory agency to a Niacin manufacturer, verifying that the manufacturing facility of a Niacin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Niacin APIs or Niacin finished pharmaceutical products to another nation, regulatory agencies frequently require a Niacin WC (written confirmation) as part of the regulatory process.
click here to find a list of Niacin 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 Niacin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Niacin 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 Niacin 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 Niacin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Niacin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Niacin suppliers with NDC on PharmaCompass.
Niacin 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 Niacin 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 Niacin GMP manufacturer or Niacin GMP API supplier for your needs.
A Niacin CoA (Certificate of Analysis) is a formal document that attests to Niacin's compliance with Niacin specifications and serves as a tool for batch-level quality control.
Niacin CoA mostly includes findings from lab analyses of a specific batch. For each Niacin 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.
Niacin may be tested according to a variety of international standards, such as European Pharmacopoeia (Niacin EP), Niacin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Niacin USP).