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