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PharmaCompass offers a list of Chlorthalidone 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 Chlorthalidone manufacturer or Chlorthalidone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chlorthalidone manufacturer or Chlorthalidone supplier.
PharmaCompass also assists you with knowing the Chlorthalidone API Price utilized in the formulation of products. Chlorthalidone API Price is not always fixed or binding as the Chlorthalidone Price is obtained through a variety of data sources. The Chlorthalidone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Chlortalidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlortalidone, including repackagers and relabelers. The FDA regulates Chlortalidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlortalidone 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 Chlortalidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlortalidone supplier is an individual or a company that provides Chlortalidone active pharmaceutical ingredient (API) or Chlortalidone finished formulations upon request. The Chlortalidone suppliers may include Chlortalidone API manufacturers, exporters, distributors and traders.
click here to find a list of Chlortalidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlortalidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlortalidone active pharmaceutical ingredient (API) in detail. Different forms of Chlortalidone DMFs exist exist since differing nations have different regulations, such as Chlortalidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlortalidone DMF submitted to regulatory agencies in the US is known as a USDMF. Chlortalidone USDMF includes data on Chlortalidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlortalidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlortalidone suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Chlortalidone Drug Master File in Korea (Chlortalidone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chlortalidone. The MFDS reviews the Chlortalidone KDMF as part of the drug registration process and uses the information provided in the Chlortalidone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chlortalidone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Chlortalidone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chlortalidone suppliers with KDMF on PharmaCompass.
A Chlortalidone CEP of the European Pharmacopoeia monograph is often referred to as a Chlortalidone Certificate of Suitability (COS). The purpose of a Chlortalidone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chlortalidone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chlortalidone to their clients by showing that a Chlortalidone CEP has been issued for it. The manufacturer submits a Chlortalidone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chlortalidone CEP holder for the record. Additionally, the data presented in the Chlortalidone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chlortalidone DMF.
A Chlortalidone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chlortalidone 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 Chlortalidone suppliers with CEP (COS) on PharmaCompass.
A Chlortalidone written confirmation (Chlortalidone WC) is an official document issued by a regulatory agency to a Chlortalidone manufacturer, verifying that the manufacturing facility of a Chlortalidone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlortalidone APIs or Chlortalidone finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlortalidone WC (written confirmation) as part of the regulatory process.
click here to find a list of Chlortalidone 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 Chlortalidone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlortalidone 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 Chlortalidone 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 Chlortalidone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlortalidone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chlortalidone suppliers with NDC on PharmaCompass.
Chlortalidone 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 Chlortalidone 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 Chlortalidone GMP manufacturer or Chlortalidone GMP API supplier for your needs.
A Chlortalidone CoA (Certificate of Analysis) is a formal document that attests to Chlortalidone's compliance with Chlortalidone specifications and serves as a tool for batch-level quality control.
Chlortalidone CoA mostly includes findings from lab analyses of a specific batch. For each Chlortalidone 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.
Chlortalidone may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlortalidone EP), Chlortalidone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlortalidone USP).
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