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API SUPPLIERS
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USDMF
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Pfanstiehl
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ABOUT THIS PAGE
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PharmaCompass offers a list of Potassium Acetate 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 Acetate manufacturer or Potassium Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Potassium Acetate manufacturer or Potassium Acetate supplier.
PharmaCompass also assists you with knowing the Potassium Acetate API Price utilized in the formulation of products. Potassium Acetate API Price is not always fixed or binding as the Potassium Acetate Price is obtained through a variety of data sources. The Potassium Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A E261 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E261, including repackagers and relabelers. The FDA regulates E261 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E261 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 E261 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A E261 supplier is an individual or a company that provides E261 active pharmaceutical ingredient (API) or E261 finished formulations upon request. The E261 suppliers may include E261 API manufacturers, exporters, distributors and traders.
click here to find a list of E261 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A E261 DMF (Drug Master File) is a document detailing the whole manufacturing process of E261 active pharmaceutical ingredient (API) in detail. Different forms of E261 DMFs exist exist since differing nations have different regulations, such as E261 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A E261 DMF submitted to regulatory agencies in the US is known as a USDMF. E261 USDMF includes data on E261's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The E261 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of E261 suppliers with USDMF on PharmaCompass.
A E261 CEP of the European Pharmacopoeia monograph is often referred to as a E261 Certificate of Suitability (COS). The purpose of a E261 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of E261 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of E261 to their clients by showing that a E261 CEP has been issued for it. The manufacturer submits a E261 CEP (COS) as part of the market authorization procedure, and it takes on the role of a E261 CEP holder for the record. Additionally, the data presented in the E261 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the E261 DMF.
A E261 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. E261 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 E261 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 E261 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for E261 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 E261 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 E261 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a E261 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of E261 suppliers with NDC on PharmaCompass.
E261 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 E261 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 E261 GMP manufacturer or E261 GMP API supplier for your needs.
A E261 CoA (Certificate of Analysis) is a formal document that attests to E261's compliance with E261 specifications and serves as a tool for batch-level quality control.
E261 CoA mostly includes findings from lab analyses of a specific batch. For each E261 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.
E261 may be tested according to a variety of international standards, such as European Pharmacopoeia (E261 EP), E261 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (E261 USP).
