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