API Suppliers
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Listed Suppliers
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USA (Orange Book)
Europe
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South Africa
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U.S. Medicaid
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PharmaCompass offers a list of Dexbrompheniramine Maleate 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 Dexbrompheniramine Maleate manufacturer or Dexbrompheniramine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexbrompheniramine Maleate manufacturer or Dexbrompheniramine Maleate supplier.
PharmaCompass also assists you with knowing the Dexbrompheniramine Maleate API Price utilized in the formulation of products. Dexbrompheniramine Maleate API Price is not always fixed or binding as the Dexbrompheniramine Maleate Price is obtained through a variety of data sources. The Dexbrompheniramine Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dexbrompheniramine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexbrompheniramine Maleate, including repackagers and relabelers. The FDA regulates Dexbrompheniramine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexbrompheniramine Maleate 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 Dexbrompheniramine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexbrompheniramine Maleate supplier is an individual or a company that provides Dexbrompheniramine Maleate active pharmaceutical ingredient (API) or Dexbrompheniramine Maleate finished formulations upon request. The Dexbrompheniramine Maleate suppliers may include Dexbrompheniramine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Dexbrompheniramine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexbrompheniramine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexbrompheniramine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Dexbrompheniramine Maleate DMFs exist exist since differing nations have different regulations, such as Dexbrompheniramine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexbrompheniramine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Dexbrompheniramine Maleate USDMF includes data on Dexbrompheniramine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexbrompheniramine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Dexbrompheniramine Maleate written confirmation (Dexbrompheniramine Maleate WC) is an official document issued by a regulatory agency to a Dexbrompheniramine Maleate manufacturer, verifying that the manufacturing facility of a Dexbrompheniramine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexbrompheniramine Maleate APIs or Dexbrompheniramine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexbrompheniramine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexbrompheniramine Maleate 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 Dexbrompheniramine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexbrompheniramine Maleate 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 Dexbrompheniramine Maleate 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 Dexbrompheniramine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexbrompheniramine Maleate NDC to their finished compounded human drug products, they may choose to do so.
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Dexbrompheniramine Maleate 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 Dexbrompheniramine Maleate 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 Dexbrompheniramine Maleate GMP manufacturer or Dexbrompheniramine Maleate GMP API supplier for your needs.
A Dexbrompheniramine Maleate CoA (Certificate of Analysis) is a formal document that attests to Dexbrompheniramine Maleate's compliance with Dexbrompheniramine Maleate specifications and serves as a tool for batch-level quality control.
Dexbrompheniramine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Dexbrompheniramine Maleate 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.
Dexbrompheniramine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexbrompheniramine Maleate EP), Dexbrompheniramine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexbrompheniramine Maleate USP).