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