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