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