X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
59
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 preventative factor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of preventative factor, including repackagers and relabelers. The FDA regulates preventative factor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. preventative factor 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 preventative factor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A preventative factor supplier is an individual or a company that provides preventative factor active pharmaceutical ingredient (API) or preventative factor finished formulations upon request. The preventative factor suppliers may include preventative factor API manufacturers, exporters, distributors and traders.
click here to find a list of preventative factor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A preventative factor DMF (Drug Master File) is a document detailing the whole manufacturing process of preventative factor active pharmaceutical ingredient (API) in detail. Different forms of preventative factor DMFs exist exist since differing nations have different regulations, such as preventative factor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A preventative factor DMF submitted to regulatory agencies in the US is known as a USDMF. preventative factor USDMF includes data on preventative factor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The preventative factor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of preventative factor 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 preventative factor Drug Master File in Japan (preventative factor JDMF) empowers preventative factor 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 preventative factor JDMF during the approval evaluation for pharmaceutical products. At the time of preventative factor 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 preventative factor suppliers with JDMF on PharmaCompass.
A preventative factor CEP of the European Pharmacopoeia monograph is often referred to as a preventative factor Certificate of Suitability (COS). The purpose of a preventative factor CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of preventative factor EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of preventative factor to their clients by showing that a preventative factor CEP has been issued for it. The manufacturer submits a preventative factor CEP (COS) as part of the market authorization procedure, and it takes on the role of a preventative factor CEP holder for the record. Additionally, the data presented in the preventative factor CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the preventative factor DMF.
A preventative factor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. preventative factor 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 preventative factor suppliers with CEP (COS) on PharmaCompass.
A preventative factor written confirmation (preventative factor WC) is an official document issued by a regulatory agency to a preventative factor manufacturer, verifying that the manufacturing facility of a preventative factor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting preventative factor APIs or preventative factor finished pharmaceutical products to another nation, regulatory agencies frequently require a preventative factor WC (written confirmation) as part of the regulatory process.
click here to find a list of preventative factor 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 preventative factor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for preventative factor 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 preventative factor 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 preventative factor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a preventative factor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of preventative factor suppliers with NDC on PharmaCompass.
preventative factor 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 preventative factor 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 preventative factor GMP manufacturer or preventative factor GMP API supplier for your needs.
A preventative factor CoA (Certificate of Analysis) is a formal document that attests to preventative factor's compliance with preventative factor specifications and serves as a tool for batch-level quality control.
preventative factor CoA mostly includes findings from lab analyses of a specific batch. For each preventative factor 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.
preventative factor may be tested according to a variety of international standards, such as European Pharmacopoeia (preventative factor EP), preventative factor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (preventative factor USP).
Market Place
