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