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API SUPPLIERS
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USDMF
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17143
Submission : 2004-02-04
Status :
Type : II
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Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Certificate Number : CEP 2018-081 - Rev 02
Status : Valid
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 659
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API Imports and Exports
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FDF Dossiers
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Chlorhexidine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorhexidine Hydrochloride, including repackagers and relabelers. The FDA regulates Chlorhexidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorhexidine 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 Chlorhexidine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorhexidine Hydrochloride supplier is an individual or a company that provides Chlorhexidine Hydrochloride active pharmaceutical ingredient (API) or Chlorhexidine Hydrochloride finished formulations upon request. The Chlorhexidine Hydrochloride suppliers may include Chlorhexidine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorhexidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorhexidine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorhexidine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Chlorhexidine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Chlorhexidine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorhexidine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorhexidine Hydrochloride USDMF includes data on Chlorhexidine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorhexidine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlorhexidine 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 Chlorhexidine Hydrochloride Drug Master File in Japan (Chlorhexidine Hydrochloride JDMF) empowers Chlorhexidine 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 Chlorhexidine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Chlorhexidine 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 Chlorhexidine Hydrochloride suppliers with JDMF on PharmaCompass.
A Chlorhexidine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Chlorhexidine Hydrochloride Certificate of Suitability (COS). The purpose of a Chlorhexidine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chlorhexidine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chlorhexidine Hydrochloride to their clients by showing that a Chlorhexidine Hydrochloride CEP has been issued for it. The manufacturer submits a Chlorhexidine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chlorhexidine Hydrochloride CEP holder for the record. Additionally, the data presented in the Chlorhexidine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chlorhexidine Hydrochloride DMF.
A Chlorhexidine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chlorhexidine 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 Chlorhexidine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Chlorhexidine Hydrochloride written confirmation (Chlorhexidine Hydrochloride WC) is an official document issued by a regulatory agency to a Chlorhexidine Hydrochloride manufacturer, verifying that the manufacturing facility of a Chlorhexidine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlorhexidine Hydrochloride APIs or Chlorhexidine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlorhexidine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Chlorhexidine 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 Chlorhexidine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlorhexidine 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 Chlorhexidine 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 Chlorhexidine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlorhexidine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chlorhexidine Hydrochloride suppliers with NDC on PharmaCompass.
Chlorhexidine 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 Chlorhexidine 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 Chlorhexidine Hydrochloride GMP manufacturer or Chlorhexidine Hydrochloride GMP API supplier for your needs.
A Chlorhexidine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Chlorhexidine Hydrochloride's compliance with Chlorhexidine Hydrochloride specifications and serves as a tool for batch-level quality control.
Chlorhexidine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Chlorhexidine 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.
Chlorhexidine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlorhexidine Hydrochloride EP), Chlorhexidine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlorhexidine Hydrochloride USP).
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