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