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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 : 9573
Submission : 1992-03-10
Status :
Type : II
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ABOUT THIS PAGE
A Chlorhexidine Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorhexidine Acetate, including repackagers and relabelers. The FDA regulates Chlorhexidine Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorhexidine Acetate 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 Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorhexidine Acetate supplier is an individual or a company that provides Chlorhexidine Acetate active pharmaceutical ingredient (API) or Chlorhexidine Acetate finished formulations upon request. The Chlorhexidine Acetate suppliers may include Chlorhexidine Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorhexidine Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorhexidine Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorhexidine Acetate active pharmaceutical ingredient (API) in detail. Different forms of Chlorhexidine Acetate DMFs exist exist since differing nations have different regulations, such as Chlorhexidine Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorhexidine Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorhexidine Acetate USDMF includes data on Chlorhexidine Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorhexidine Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlorhexidine Acetate suppliers with USDMF on PharmaCompass.
A Chlorhexidine Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Chlorhexidine Acetate Certificate of Suitability (COS). The purpose of a Chlorhexidine Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chlorhexidine Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chlorhexidine Acetate to their clients by showing that a Chlorhexidine Acetate CEP has been issued for it. The manufacturer submits a Chlorhexidine Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chlorhexidine Acetate CEP holder for the record. Additionally, the data presented in the Chlorhexidine Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chlorhexidine Acetate DMF.
A Chlorhexidine Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chlorhexidine Acetate 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 Acetate suppliers with CEP (COS) on PharmaCompass.
A Chlorhexidine Acetate written confirmation (Chlorhexidine Acetate WC) is an official document issued by a regulatory agency to a Chlorhexidine Acetate manufacturer, verifying that the manufacturing facility of a Chlorhexidine Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlorhexidine Acetate APIs or Chlorhexidine Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlorhexidine Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Chlorhexidine Acetate 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 Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlorhexidine Acetate 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 Acetate 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 Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlorhexidine Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chlorhexidine Acetate suppliers with NDC on PharmaCompass.
Chlorhexidine Acetate 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 Acetate 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 Acetate GMP manufacturer or Chlorhexidine Acetate GMP API supplier for your needs.
A Chlorhexidine Acetate CoA (Certificate of Analysis) is a formal document that attests to Chlorhexidine Acetate's compliance with Chlorhexidine Acetate specifications and serves as a tool for batch-level quality control.
Chlorhexidine Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Chlorhexidine Acetate 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 Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlorhexidine Acetate EP), Chlorhexidine Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlorhexidine Acetate USP).
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