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