US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Benzyl Alcohol API 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 Benzyl Alcohol API manufacturer or Benzyl Alcohol API supplier for your needs.
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PharmaCompass also assists you with knowing the Benzyl Alcohol API API Price utilized in the formulation of products. Benzyl Alcohol API API Price is not always fixed or binding as the Benzyl Alcohol API Price is obtained through a variety of data sources. The Benzyl Alcohol API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benzyl Alcohol API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzyl Alcohol API, including repackagers and relabelers. The FDA regulates Benzyl Alcohol API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzyl Alcohol API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Benzyl Alcohol API supplier is an individual or a company that provides Benzyl Alcohol API active pharmaceutical ingredient (API) or Benzyl Alcohol API finished formulations upon request. The Benzyl Alcohol API suppliers may include Benzyl Alcohol API API manufacturers, exporters, distributors and traders.
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A Benzyl Alcohol API DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzyl Alcohol API active pharmaceutical ingredient (API) in detail. Different forms of Benzyl Alcohol API DMFs exist exist since differing nations have different regulations, such as Benzyl Alcohol API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzyl Alcohol API DMF submitted to regulatory agencies in the US is known as a USDMF. Benzyl Alcohol API USDMF includes data on Benzyl Alcohol API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzyl Alcohol API USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Benzyl Alcohol API CEP of the European Pharmacopoeia monograph is often referred to as a Benzyl Alcohol API Certificate of Suitability (COS). The purpose of a Benzyl Alcohol API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benzyl Alcohol API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benzyl Alcohol API to their clients by showing that a Benzyl Alcohol API CEP has been issued for it. The manufacturer submits a Benzyl Alcohol API CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benzyl Alcohol API CEP holder for the record. Additionally, the data presented in the Benzyl Alcohol API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benzyl Alcohol API DMF.
A Benzyl Alcohol API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benzyl Alcohol API 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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Benzyl Alcohol API 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 Benzyl Alcohol API 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 Benzyl Alcohol API GMP manufacturer or Benzyl Alcohol API GMP API supplier for your needs.
A Benzyl Alcohol API CoA (Certificate of Analysis) is a formal document that attests to Benzyl Alcohol API's compliance with Benzyl Alcohol API specifications and serves as a tool for batch-level quality control.
Benzyl Alcohol API CoA mostly includes findings from lab analyses of a specific batch. For each Benzyl Alcohol API 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.
Benzyl Alcohol API may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzyl Alcohol API EP), Benzyl Alcohol API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzyl Alcohol API USP).