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PharmaCompass offers a list of Potassium Nitrate 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 Potassium Nitrate manufacturer or Potassium Nitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Potassium Nitrate manufacturer or Potassium Nitrate supplier.
PharmaCompass also assists you with knowing the Potassium Nitrate API Price utilized in the formulation of products. Potassium Nitrate API Price is not always fixed or binding as the Potassium Nitrate Price is obtained through a variety of data sources. The Potassium Nitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Potassium Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Nitrate, including repackagers and relabelers. The FDA regulates Potassium Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Nitrate 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 Potassium Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Nitrate supplier is an individual or a company that provides Potassium Nitrate active pharmaceutical ingredient (API) or Potassium Nitrate finished formulations upon request. The Potassium Nitrate suppliers may include Potassium Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Nitrate DMFs exist exist since differing nations have different regulations, such as Potassium Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Nitrate USDMF includes data on Potassium Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Nitrate suppliers with USDMF 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 Potassium Nitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Potassium Nitrate 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 Potassium Nitrate 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 Potassium Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Potassium Nitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Potassium Nitrate suppliers with NDC on PharmaCompass.
Potassium Nitrate 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 Potassium Nitrate 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 Potassium Nitrate GMP manufacturer or Potassium Nitrate GMP API supplier for your needs.
A Potassium Nitrate CoA (Certificate of Analysis) is a formal document that attests to Potassium Nitrate's compliance with Potassium Nitrate specifications and serves as a tool for batch-level quality control.
Potassium Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Potassium Nitrate 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.
Potassium Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Potassium Nitrate EP), Potassium Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Potassium Nitrate USP).