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