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PharmaCompass offers a list of Busulfan 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 Busulfan manufacturer or Busulfan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Busulfan manufacturer or Busulfan supplier.
PharmaCompass also assists you with knowing the Busulfan API Price utilized in the formulation of products. Busulfan API Price is not always fixed or binding as the Busulfan Price is obtained through a variety of data sources. The Busulfan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1,4-Dimethane sulfonyl oxybutane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,4-Dimethane sulfonyl oxybutane, including repackagers and relabelers. The FDA regulates 1,4-Dimethane sulfonyl oxybutane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1,4-Dimethane sulfonyl oxybutane supplier is an individual or a company that provides 1,4-Dimethane sulfonyl oxybutane active pharmaceutical ingredient (API) or 1,4-Dimethane sulfonyl oxybutane finished formulations upon request. The 1,4-Dimethane sulfonyl oxybutane suppliers may include 1,4-Dimethane sulfonyl oxybutane API manufacturers, exporters, distributors and traders.
click here to find a list of 1,4-Dimethane sulfonyl oxybutane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1,4-Dimethane sulfonyl oxybutane DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,4-Dimethane sulfonyl oxybutane active pharmaceutical ingredient (API) in detail. Different forms of 1,4-Dimethane sulfonyl oxybutane DMFs exist exist since differing nations have different regulations, such as 1,4-Dimethane sulfonyl oxybutane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,4-Dimethane sulfonyl oxybutane DMF submitted to regulatory agencies in the US is known as a USDMF. 1,4-Dimethane sulfonyl oxybutane USDMF includes data on 1,4-Dimethane sulfonyl oxybutane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,4-Dimethane sulfonyl oxybutane USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 1,4-Dimethane sulfonyl oxybutane Drug Master File in Japan (1,4-Dimethane sulfonyl oxybutane JDMF) empowers 1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane JDMF during the approval evaluation for pharmaceutical products. At the time of 1,4-Dimethane sulfonyl oxybutane JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,4-Dimethane sulfonyl oxybutane Drug Master File in Korea (1,4-Dimethane sulfonyl oxybutane KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,4-Dimethane sulfonyl oxybutane. The MFDS reviews the 1,4-Dimethane sulfonyl oxybutane KDMF as part of the drug registration process and uses the information provided in the 1,4-Dimethane sulfonyl oxybutane KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane API can apply through the Korea Drug Master File (KDMF).
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A 1,4-Dimethane sulfonyl oxybutane CEP of the European Pharmacopoeia monograph is often referred to as a 1,4-Dimethane sulfonyl oxybutane Certificate of Suitability (COS). The purpose of a 1,4-Dimethane sulfonyl oxybutane CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1,4-Dimethane sulfonyl oxybutane EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1,4-Dimethane sulfonyl oxybutane to their clients by showing that a 1,4-Dimethane sulfonyl oxybutane CEP has been issued for it. The manufacturer submits a 1,4-Dimethane sulfonyl oxybutane CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1,4-Dimethane sulfonyl oxybutane CEP holder for the record. Additionally, the data presented in the 1,4-Dimethane sulfonyl oxybutane CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1,4-Dimethane sulfonyl oxybutane DMF.
A 1,4-Dimethane sulfonyl oxybutane CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1,4-Dimethane sulfonyl oxybutane CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A 1,4-Dimethane sulfonyl oxybutane written confirmation (1,4-Dimethane sulfonyl oxybutane WC) is an official document issued by a regulatory agency to a 1,4-Dimethane sulfonyl oxybutane manufacturer, verifying that the manufacturing facility of a 1,4-Dimethane sulfonyl oxybutane active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1,4-Dimethane sulfonyl oxybutane APIs or 1,4-Dimethane sulfonyl oxybutane finished pharmaceutical products to another nation, regulatory agencies frequently require a 1,4-Dimethane sulfonyl oxybutane WC (written confirmation) as part of the regulatory process.
click here to find a list of 1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1,4-Dimethane sulfonyl oxybutane NDC to their finished compounded human drug products, they may choose to do so.
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1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane 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 1,4-Dimethane sulfonyl oxybutane GMP manufacturer or 1,4-Dimethane sulfonyl oxybutane GMP API supplier for your needs.
A 1,4-Dimethane sulfonyl oxybutane CoA (Certificate of Analysis) is a formal document that attests to 1,4-Dimethane sulfonyl oxybutane's compliance with 1,4-Dimethane sulfonyl oxybutane specifications and serves as a tool for batch-level quality control.
1,4-Dimethane sulfonyl oxybutane CoA mostly includes findings from lab analyses of a specific batch. For each 1,4-Dimethane sulfonyl oxybutane 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.
1,4-Dimethane sulfonyl oxybutane may be tested according to a variety of international standards, such as European Pharmacopoeia (1,4-Dimethane sulfonyl oxybutane EP), 1,4-Dimethane sulfonyl oxybutane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1,4-Dimethane sulfonyl oxybutane USP).
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