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