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