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