Synopsis
0
VMF
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
48
PharmaCompass offers a list of Colistimethate Sodium 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 Colistimethate Sodium manufacturer or Colistimethate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Colistimethate Sodium manufacturer or Colistimethate Sodium supplier.
PharmaCompass also assists you with knowing the Colistimethate Sodium API Price utilized in the formulation of products. Colistimethate Sodium API Price is not always fixed or binding as the Colistimethate Sodium Price is obtained through a variety of data sources. The Colistimethate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sodium colistin methanesulfonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium colistin methanesulfonate, including repackagers and relabelers. The FDA regulates Sodium colistin methanesulfonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium colistin methanesulfonate 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 Sodium colistin methanesulfonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium colistin methanesulfonate supplier is an individual or a company that provides Sodium colistin methanesulfonate active pharmaceutical ingredient (API) or Sodium colistin methanesulfonate finished formulations upon request. The Sodium colistin methanesulfonate suppliers may include Sodium colistin methanesulfonate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium colistin methanesulfonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium colistin methanesulfonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium colistin methanesulfonate active pharmaceutical ingredient (API) in detail. Different forms of Sodium colistin methanesulfonate DMFs exist exist since differing nations have different regulations, such as Sodium colistin methanesulfonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium colistin methanesulfonate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium colistin methanesulfonate USDMF includes data on Sodium colistin methanesulfonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium colistin methanesulfonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium colistin methanesulfonate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Sodium colistin methanesulfonate Drug Master File in Japan (Sodium colistin methanesulfonate JDMF) empowers Sodium colistin methanesulfonate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Sodium colistin methanesulfonate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium colistin methanesulfonate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Sodium colistin methanesulfonate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sodium colistin methanesulfonate Drug Master File in Korea (Sodium colistin methanesulfonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium colistin methanesulfonate. The MFDS reviews the Sodium colistin methanesulfonate KDMF as part of the drug registration process and uses the information provided in the Sodium colistin methanesulfonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sodium colistin methanesulfonate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sodium colistin methanesulfonate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sodium colistin methanesulfonate suppliers with KDMF on PharmaCompass.
A Sodium colistin methanesulfonate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium colistin methanesulfonate Certificate of Suitability (COS). The purpose of a Sodium colistin methanesulfonate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium colistin methanesulfonate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium colistin methanesulfonate to their clients by showing that a Sodium colistin methanesulfonate CEP has been issued for it. The manufacturer submits a Sodium colistin methanesulfonate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium colistin methanesulfonate CEP holder for the record. Additionally, the data presented in the Sodium colistin methanesulfonate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium colistin methanesulfonate DMF.
A Sodium colistin methanesulfonate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium colistin methanesulfonate 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 Sodium colistin methanesulfonate suppliers with CEP (COS) on PharmaCompass.
A Sodium colistin methanesulfonate written confirmation (Sodium colistin methanesulfonate WC) is an official document issued by a regulatory agency to a Sodium colistin methanesulfonate manufacturer, verifying that the manufacturing facility of a Sodium colistin methanesulfonate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium colistin methanesulfonate APIs or Sodium colistin methanesulfonate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium colistin methanesulfonate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium colistin methanesulfonate 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 Sodium colistin methanesulfonate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium colistin methanesulfonate 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 Sodium colistin methanesulfonate 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 Sodium colistin methanesulfonate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium colistin methanesulfonate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium colistin methanesulfonate suppliers with NDC on PharmaCompass.
Sodium colistin methanesulfonate 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 Sodium colistin methanesulfonate 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 Sodium colistin methanesulfonate GMP manufacturer or Sodium colistin methanesulfonate GMP API supplier for your needs.
A Sodium colistin methanesulfonate CoA (Certificate of Analysis) is a formal document that attests to Sodium colistin methanesulfonate's compliance with Sodium colistin methanesulfonate specifications and serves as a tool for batch-level quality control.
Sodium colistin methanesulfonate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium colistin methanesulfonate 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.
Sodium colistin methanesulfonate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium colistin methanesulfonate EP), Sodium colistin methanesulfonate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium colistin methanesulfonate USP).
