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