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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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ABOUT THIS PAGE
57
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 Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Primaquine Phosphate, including repackagers and relabelers. The FDA regulates Primaquine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Primaquine Phosphate 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 Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Primaquine Phosphate supplier is an individual or a company that provides Primaquine Phosphate active pharmaceutical ingredient (API) or Primaquine Phosphate finished formulations upon request. The Primaquine Phosphate suppliers may include Primaquine Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Primaquine Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Primaquine Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Primaquine Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Primaquine Phosphate DMFs exist exist since differing nations have different regulations, such as Primaquine Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Primaquine Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Primaquine Phosphate USDMF includes data on Primaquine Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Primaquine Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Primaquine Phosphate suppliers with USDMF on PharmaCompass.
A Primaquine Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Primaquine Phosphate Certificate of Suitability (COS). The purpose of a Primaquine Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Primaquine Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Primaquine Phosphate to their clients by showing that a Primaquine Phosphate CEP has been issued for it. The manufacturer submits a Primaquine Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Primaquine Phosphate CEP holder for the record. Additionally, the data presented in the Primaquine Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Primaquine Phosphate DMF.
A Primaquine Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Primaquine Phosphate 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 Phosphate suppliers with CEP (COS) on PharmaCompass.
A Primaquine Phosphate written confirmation (Primaquine Phosphate WC) is an official document issued by a regulatory agency to a Primaquine Phosphate manufacturer, verifying that the manufacturing facility of a Primaquine Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Primaquine Phosphate APIs or Primaquine Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Primaquine Phosphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Primaquine Phosphate 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 Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Primaquine Phosphate 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 Phosphate 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 Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Primaquine Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Primaquine Phosphate suppliers with NDC on PharmaCompass.
Primaquine Phosphate 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 Phosphate 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 Phosphate GMP manufacturer or Primaquine Phosphate GMP API supplier for your needs.
A Primaquine Phosphate CoA (Certificate of Analysis) is a formal document that attests to Primaquine Phosphate's compliance with Primaquine Phosphate specifications and serves as a tool for batch-level quality control.
Primaquine Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Primaquine Phosphate 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 Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Primaquine Phosphate EP), Primaquine Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Primaquine Phosphate USP).
