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