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