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