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