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