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PharmaCompass offers a list of Nicotinamide 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 Nicotinamide manufacturer or Nicotinamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nicotinamide manufacturer or Nicotinamide supplier.
PharmaCompass also assists you with knowing the Nicotinamide API Price utilized in the formulation of products. Nicotinamide API Price is not always fixed or binding as the Nicotinamide Price is obtained through a variety of data sources. The Nicotinamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Niacinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niacinamide, including repackagers and relabelers. The FDA regulates Niacinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niacinamide 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 Niacinamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niacinamide supplier is an individual or a company that provides Niacinamide active pharmaceutical ingredient (API) or Niacinamide finished formulations upon request. The Niacinamide suppliers may include Niacinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Niacinamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niacinamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Niacinamide active pharmaceutical ingredient (API) in detail. Different forms of Niacinamide DMFs exist exist since differing nations have different regulations, such as Niacinamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niacinamide DMF submitted to regulatory agencies in the US is known as a USDMF. Niacinamide USDMF includes data on Niacinamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niacinamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niacinamide 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 Niacinamide Drug Master File in Japan (Niacinamide JDMF) empowers Niacinamide 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 Niacinamide JDMF during the approval evaluation for pharmaceutical products. At the time of Niacinamide 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 Niacinamide suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Niacinamide Drug Master File in Korea (Niacinamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Niacinamide. The MFDS reviews the Niacinamide KDMF as part of the drug registration process and uses the information provided in the Niacinamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Niacinamide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Niacinamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Niacinamide suppliers with KDMF on PharmaCompass.
A Niacinamide CEP of the European Pharmacopoeia monograph is often referred to as a Niacinamide Certificate of Suitability (COS). The purpose of a Niacinamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Niacinamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Niacinamide to their clients by showing that a Niacinamide CEP has been issued for it. The manufacturer submits a Niacinamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Niacinamide CEP holder for the record. Additionally, the data presented in the Niacinamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Niacinamide DMF.
A Niacinamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Niacinamide 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 Niacinamide suppliers with CEP (COS) on PharmaCompass.
A Niacinamide written confirmation (Niacinamide WC) is an official document issued by a regulatory agency to a Niacinamide manufacturer, verifying that the manufacturing facility of a Niacinamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Niacinamide APIs or Niacinamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Niacinamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Niacinamide 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 Niacinamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Niacinamide 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 Niacinamide 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 Niacinamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Niacinamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Niacinamide suppliers with NDC on PharmaCompass.
Niacinamide 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 Niacinamide 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 Niacinamide GMP manufacturer or Niacinamide GMP API supplier for your needs.
A Niacinamide CoA (Certificate of Analysis) is a formal document that attests to Niacinamide's compliance with Niacinamide specifications and serves as a tool for batch-level quality control.
Niacinamide CoA mostly includes findings from lab analyses of a specific batch. For each Niacinamide 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.
Niacinamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Niacinamide EP), Niacinamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Niacinamide USP).
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