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