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