X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
94
PharmaCompass offers a list of Primaquine Diphosphate 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 Primaquine Diphosphate manufacturer or Primaquine Diphosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Primaquine Diphosphate manufacturer or Primaquine Diphosphate supplier.
PharmaCompass also assists you with knowing the Primaquine Diphosphate API Price utilized in the formulation of products. Primaquine Diphosphate API Price is not always fixed or binding as the Primaquine Diphosphate Price is obtained through a variety of data sources. The Primaquine Diphosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Primaquine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Primaquine, including repackagers and relabelers. The FDA regulates Primaquine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Primaquine 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 Primaquine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Primaquine supplier is an individual or a company that provides Primaquine active pharmaceutical ingredient (API) or Primaquine finished formulations upon request. The Primaquine suppliers may include Primaquine API manufacturers, exporters, distributors and traders.
click here to find a list of Primaquine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Primaquine DMF (Drug Master File) is a document detailing the whole manufacturing process of Primaquine active pharmaceutical ingredient (API) in detail. Different forms of Primaquine DMFs exist exist since differing nations have different regulations, such as Primaquine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Primaquine DMF submitted to regulatory agencies in the US is known as a USDMF. Primaquine USDMF includes data on Primaquine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Primaquine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Primaquine suppliers with USDMF on PharmaCompass.
A Primaquine CEP of the European Pharmacopoeia monograph is often referred to as a Primaquine Certificate of Suitability (COS). The purpose of a Primaquine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Primaquine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Primaquine to their clients by showing that a Primaquine CEP has been issued for it. The manufacturer submits a Primaquine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Primaquine CEP holder for the record. Additionally, the data presented in the Primaquine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Primaquine DMF.
A Primaquine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Primaquine 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 Primaquine suppliers with CEP (COS) on PharmaCompass.
A Primaquine written confirmation (Primaquine WC) is an official document issued by a regulatory agency to a Primaquine manufacturer, verifying that the manufacturing facility of a Primaquine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Primaquine APIs or Primaquine finished pharmaceutical products to another nation, regulatory agencies frequently require a Primaquine WC (written confirmation) as part of the regulatory process.
click here to find a list of Primaquine 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 Primaquine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Primaquine 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 Primaquine 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 Primaquine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Primaquine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Primaquine suppliers with NDC on PharmaCompass.
Primaquine 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 Primaquine 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 Primaquine GMP manufacturer or Primaquine GMP API supplier for your needs.
A Primaquine CoA (Certificate of Analysis) is a formal document that attests to Primaquine's compliance with Primaquine specifications and serves as a tool for batch-level quality control.
Primaquine CoA mostly includes findings from lab analyses of a specific batch. For each Primaquine 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.
Primaquine may be tested according to a variety of international standards, such as European Pharmacopoeia (Primaquine EP), Primaquine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Primaquine USP).
Market Place
