X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
67
PharmaCompass offers a list of Prilocaine 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 Prilocaine manufacturer or Prilocaine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prilocaine manufacturer or Prilocaine supplier.
PharmaCompass also assists you with knowing the Prilocaine API Price utilized in the formulation of products. Prilocaine API Price is not always fixed or binding as the Prilocaine Price is obtained through a variety of data sources. The Prilocaine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prilocaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prilocaine, including repackagers and relabelers. The FDA regulates Prilocaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prilocaine 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 Prilocaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prilocaine supplier is an individual or a company that provides Prilocaine active pharmaceutical ingredient (API) or Prilocaine finished formulations upon request. The Prilocaine suppliers may include Prilocaine API manufacturers, exporters, distributors and traders.
click here to find a list of Prilocaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prilocaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Prilocaine active pharmaceutical ingredient (API) in detail. Different forms of Prilocaine DMFs exist exist since differing nations have different regulations, such as Prilocaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prilocaine DMF submitted to regulatory agencies in the US is known as a USDMF. Prilocaine USDMF includes data on Prilocaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prilocaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prilocaine 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 Prilocaine Drug Master File in Japan (Prilocaine JDMF) empowers Prilocaine 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 Prilocaine JDMF during the approval evaluation for pharmaceutical products. At the time of Prilocaine 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 Prilocaine suppliers with JDMF on PharmaCompass.
A Prilocaine CEP of the European Pharmacopoeia monograph is often referred to as a Prilocaine Certificate of Suitability (COS). The purpose of a Prilocaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prilocaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prilocaine to their clients by showing that a Prilocaine CEP has been issued for it. The manufacturer submits a Prilocaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prilocaine CEP holder for the record. Additionally, the data presented in the Prilocaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prilocaine DMF.
A Prilocaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prilocaine 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 Prilocaine suppliers with CEP (COS) on PharmaCompass.
A Prilocaine written confirmation (Prilocaine WC) is an official document issued by a regulatory agency to a Prilocaine manufacturer, verifying that the manufacturing facility of a Prilocaine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prilocaine APIs or Prilocaine finished pharmaceutical products to another nation, regulatory agencies frequently require a Prilocaine WC (written confirmation) as part of the regulatory process.
click here to find a list of Prilocaine 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 Prilocaine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prilocaine 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 Prilocaine 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 Prilocaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prilocaine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prilocaine suppliers with NDC on PharmaCompass.
Prilocaine 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 Prilocaine 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 Prilocaine GMP manufacturer or Prilocaine GMP API supplier for your needs.
A Prilocaine CoA (Certificate of Analysis) is a formal document that attests to Prilocaine's compliance with Prilocaine specifications and serves as a tool for batch-level quality control.
Prilocaine CoA mostly includes findings from lab analyses of a specific batch. For each Prilocaine 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.
Prilocaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Prilocaine EP), Prilocaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prilocaine USP).
Market Place
