US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Candesartan Cilexetil 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 Candesartan Cilexetil manufacturer or Candesartan Cilexetil supplier for your needs.
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PharmaCompass also assists you with knowing the Candesartan Cilexetil API Price utilized in the formulation of products. Candesartan Cilexetil API Price is not always fixed or binding as the Candesartan Cilexetil Price is obtained through a variety of data sources. The Candesartan Cilexetil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Candesartan Cilexetil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Candesartan Cilexetil, including repackagers and relabelers. The FDA regulates Candesartan Cilexetil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Candesartan Cilexetil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Candesartan Cilexetil supplier is an individual or a company that provides Candesartan Cilexetil active pharmaceutical ingredient (API) or Candesartan Cilexetil finished formulations upon request. The Candesartan Cilexetil suppliers may include Candesartan Cilexetil API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Candesartan Cilexetil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Candesartan Cilexetil DMF (Drug Master File) is a document detailing the whole manufacturing process of Candesartan Cilexetil active pharmaceutical ingredient (API) in detail. Different forms of Candesartan Cilexetil DMFs exist exist since differing nations have different regulations, such as Candesartan Cilexetil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Candesartan Cilexetil DMF submitted to regulatory agencies in the US is known as a USDMF. Candesartan Cilexetil USDMF includes data on Candesartan Cilexetil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Candesartan Cilexetil USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Candesartan Cilexetil Drug Master File in Japan (Candesartan Cilexetil JDMF) empowers Candesartan Cilexetil 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 Candesartan Cilexetil JDMF during the approval evaluation for pharmaceutical products. At the time of Candesartan Cilexetil JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Candesartan Cilexetil Drug Master File in Korea (Candesartan Cilexetil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Candesartan Cilexetil. The MFDS reviews the Candesartan Cilexetil KDMF as part of the drug registration process and uses the information provided in the Candesartan Cilexetil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Candesartan Cilexetil 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 Candesartan Cilexetil API can apply through the Korea Drug Master File (KDMF).
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A Candesartan Cilexetil CEP of the European Pharmacopoeia monograph is often referred to as a Candesartan Cilexetil Certificate of Suitability (COS). The purpose of a Candesartan Cilexetil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Candesartan Cilexetil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Candesartan Cilexetil to their clients by showing that a Candesartan Cilexetil CEP has been issued for it. The manufacturer submits a Candesartan Cilexetil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Candesartan Cilexetil CEP holder for the record. Additionally, the data presented in the Candesartan Cilexetil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Candesartan Cilexetil DMF.
A Candesartan Cilexetil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Candesartan Cilexetil CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Candesartan Cilexetil written confirmation (Candesartan Cilexetil WC) is an official document issued by a regulatory agency to a Candesartan Cilexetil manufacturer, verifying that the manufacturing facility of a Candesartan Cilexetil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Candesartan Cilexetil APIs or Candesartan Cilexetil finished pharmaceutical products to another nation, regulatory agencies frequently require a Candesartan Cilexetil WC (written confirmation) as part of the regulatory process.
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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 Candesartan Cilexetil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Candesartan Cilexetil 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 Candesartan Cilexetil 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 Candesartan Cilexetil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Candesartan Cilexetil NDC to their finished compounded human drug products, they may choose to do so.
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Candesartan Cilexetil 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 Candesartan Cilexetil 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 Candesartan Cilexetil GMP manufacturer or Candesartan Cilexetil GMP API supplier for your needs.
A Candesartan Cilexetil CoA (Certificate of Analysis) is a formal document that attests to Candesartan Cilexetil's compliance with Candesartan Cilexetil specifications and serves as a tool for batch-level quality control.
Candesartan Cilexetil CoA mostly includes findings from lab analyses of a specific batch. For each Candesartan Cilexetil 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.
Candesartan Cilexetil may be tested according to a variety of international standards, such as European Pharmacopoeia (Candesartan Cilexetil EP), Candesartan Cilexetil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Candesartan Cilexetil USP).